FDA Product Code
FDA Product Code DIO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3250
510(k) Clearances — 145 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Carolina Liquid Chemistries Corp. | 2022-01-27 | Traditional | PDF ↗ |
| K211973 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2021-09-24 | Traditional | PDF ↗ |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | 2020-03-12 | Traditional | PDF ↗ |
| K181499 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2018-07-06 | Traditional | PDF ↗ |
| K170293 | Emit II Plus Cocaine Metabolite Assay | Siemens Healthcare Diagnostics, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries Corporation | 2017-08-15 | Traditional | PDF ↗ |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | 2017-06-02 | Special | PDF ↗ |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | 2016-11-18 | Traditional | PDF ↗ |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 | Traditional | PDF ↗ |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | Safecare Biotech (Hangzhou) Co., Ltd. | 2016-03-18 | Traditional | PDF ↗ |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | Biophor Diagnostics, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | Immunalysis Corporation | 2015-06-29 | Traditional | PDF ↗ |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2014-10-07 | Traditional | PDF ↗ |
| K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) | Healgen Scientific,, LLC | 2014-07-17 | Traditional | PDF ↗ |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | Omega Laboratories, Inc. | 2013-11-13 | Traditional | PDF ↗ |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-07-31 | Traditional | PDF ↗ |
| K113751 | RANDOX COCAINE METABOLITE | Randox Laboratories, Ltd. | 2012-05-08 | Traditional | PDF ↗ |
| K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | Guangzhou Wondfo Biotech Co., Ltd. | 2012-05-08 | Special | PDF ↗ |
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | Branan Medical Corporation | 2012-04-11 | Traditional | PDF ↗ |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | Phamatech, Inc. | 2012-02-01 | Traditional | PDF ↗ |
| K112808 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | Omega Laboratories, Inc. | 2012-01-23 | Traditional | PDF ↗ |
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | Ameditech, Inc. | 2011-12-05 | Special | PDF ↗ |
| K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | Lin-Zhi International, Inc. | 2011-11-22 | Traditional | PDF ↗ |
| K112071 | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-23 | Traditional | PDF ↗ |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | Microgenics Corp. | 2011-04-08 | Traditional | PDF ↗ |
| K101160 | ROCHE ORAL FLUID COCAINE | Roche Diagnostics | 2011-02-11 | Traditional | PDF ↗ |
| K080436 | RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 | Quantrx Biomedical Corporation | 2009-02-11 | Traditional | PDF ↗ |
| K062929 | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA | Quest Diagnostics, Inc. | 2006-12-18 | Traditional | PDF ↗ |
| K062123 | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | 2006-11-16 | Traditional | PDF ↗ |
| K053422 | RAPIDONE-COCAINE-150 TEST | American Bio Medica Corp. | 2006-06-15 | Traditional | PDF ↗ |
| K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 | Acro Biotech, LLC | 2006-05-05 | Traditional | PDF ↗ |
| K050945 | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS | Lin-Zhi International, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K051578 | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS | Immunalysis Corporation | 2005-11-18 | Traditional | PDF ↗ |
| K050465 | IMMUNALYSIS COCAINE ELISA FOR HAIR | Immunalysis Corporation | 2005-08-04 | Traditional | PDF ↗ |
| K050321 | ONTRAK TESTCARD 9 | Varian, Inc. | 2005-04-18 | Traditional | PDF ↗ |
| K033866 | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) | Lin-Zhi International, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K040198 | LABONE COCAINE METABOLITE MICRO-PLATE EIA | Labone, Inc. | 2004-03-05 | Traditional | PDF ↗ |
| K032903 | ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE | ACON Laboratories, Inc. | 2004-02-17 | Traditional | PDF ↗ |
| K033713 | URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A | Dade Behring, Inc. | 2004-02-09 | Traditional | PDF ↗ |
| K030360 | RANDOX EVIDENCE | Randox Laboratories, Ltd. | 2003-12-23 | Traditional | PDF ↗ |
| K023626 | AML HAIRCHECK-DT (COCAINE) | Quest Diagnostics, Inc. | 2003-09-29 | Traditional | PDF ↗ |
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | Branan Medical Corp. | 2003-08-21 | Special | PDF ↗ |
| K031512 | EMIT II PLUS COCAINE METABOLITE ASSAY | Dade Behring, Inc. | 2003-07-23 | Traditional | PDF ↗ |
| K030234 | COZART EIA COCAINE ORAL FLIUD KIT | Cozart Bioscience , Ltd. | 2003-04-28 | Traditional | PDF ↗ |
| K023489 | QUICKTOX MULTIPLE DRUG DIPCARD | Branan Medical Corp. | 2002-12-16 | Special | PDF ↗ |
| K023281 | ONLINE DAT II COCAINE II | Roche Diagnostics Corp. | 2002-12-06 | Traditional | PDF ↗ |
| K023296 | COBAS INTEGRA ONLINE DAT II COCAINE II | Roche Diagnostics Corp. | 2002-11-25 | Traditional | PDF ↗ |
| K022954 | AMEDICA DRUG SCREEN COCAINE TEST | Amedica Biotech, Inc. | 2002-11-06 | Traditional | PDF ↗ |
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 | Branan Medical Corp. | 2002-07-30 | Special | PDF ↗ |
| K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | Princeton BioMeditech Corp. | 2002-06-10 | Traditional | PDF ↗ |
| K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC | Princeton BioMeditech Corp. | 2002-06-10 | Traditional | PDF ↗ |
| K020771 | ACON ONE STEP DRUG SCREEN TEST CARD | ACON Laboratories, Inc. | 2002-05-15 | Traditional | PDF ↗ |
| K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | Lin-Zhi International, Inc. | 2002-05-10 | Traditional | PDF ↗ |
| K020441 | EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY | Dade Behring, Inc. | 2002-03-28 | Traditional | PDF ↗ |
| K013004 | COCAINE | Abbott Laboratories | 2002-03-13 | Traditional | PDF ↗ |
| K011814 | AMEDITECH IMMUTEST DRUG SCREEN COC | Ameditech, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST | Advantage Diagnostics Corp. | 2001-08-09 | Traditional | PDF ↗ |
| K011054 | RADS | Chason Healthcare, LLC | 2001-07-30 | Traditional | PDF ↗ |
| K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | ACON Laboratories, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K010239 | COCAINE DIPSTICK TEST, MODEL D747-A | Teco Diagnostics | 2001-06-25 | Traditional | PDF ↗ |
| K011162 | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY | Syva Co., Dade Behring, Inc. | 2001-05-02 | Special | PDF ↗ |
| K010967 | LIVESURE COCAINE SCREEN TEST | Pan Probe Biotech, Inc. | 2001-04-17 | Traditional | PDF ↗ |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | Phamatech | 2001-04-11 | Special | PDF ↗ |
| K010650 | AT HOME DRUG TEST, MODEL 9073 T | Phamatech | 2001-03-30 | Special | PDF ↗ |
| K003708 | ADVANTAGE THC/COCAINE TEST | Advantage Diagnostics Corp. | 2001-01-22 | Traditional | PDF ↗ |
| K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | Branan Medical Corporation | 2000-11-27 | Traditional | PDF ↗ |
| K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-08-14 | Traditional | PDF ↗ |
| K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-07-27 | Traditional | PDF ↗ |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | OraSure Technologies, Inc. | 2000-05-11 | Special | PDF ↗ |
| K000467 | URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A | Dade Behring, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K000350 | SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST | Drug Detection Devices, Ltd. | 2000-04-11 | Traditional | PDF ↗ |
| K994165 | ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 | Roche Diagnostics Corp. | 2000-04-07 | Traditional | PDF ↗ |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | Syva Co. | 2000-01-27 | Traditional | PDF ↗ |
| K994219 | AT HOME DRUG TEST, MODEL 9073 | Phamatech | 1999-12-30 | Special | PDF ↗ |
| K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE | Sun Biomedical Laboratories, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | Syntron Bioresearch, Inc. | 1999-09-20 | Traditional | PDF ↗ |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | Syntron Bioresearch, Inc. | 1999-09-02 | Traditional | PDF ↗ |
| K991110 | REDI-TEST COCAINE | Redwood Biotech, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | Syntron Bioresearch, Inc. | 1999-07-22 | Traditional | PDF ↗ |
| K990822 | RAPIDONE - COCAINE TEST | American Bio Medica Corp. | 1999-07-15 | Traditional | PDF ↗ |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1998-12-11 | Special | PDF ↗ |
| K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U | OraSure Technologies, Inc. | 1998-11-20 | Traditional | PDF ↗ |
| K983388 | ONTRAK TESTCUP-ER | Roche Diagnostic Systems, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983191 | DBEST COCAINE TEST KIT | Ameritek, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) | OraSure Technologies, Inc. | 1998-08-25 | Traditional | PDF ↗ |
| K981388 | MICRO-STRIP FOR COCAINE METABOLITES | Microdiagnostics, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K973986 | MECTEST | Meco Industries | 1998-04-24 | Traditional | PDF ↗ |
| K980153 | DRUG CHECK | Texas Immunology, Inc. | 1998-03-27 | Traditional | PDF ↗ |
| K980872 | RAPID DRUG SCREEN' 8 PANEL | American Bio Medica Corp. | 1998-03-20 | Traditional | PDF ↗ |
| K973651 | STC COCAINE METABOLITE MICRO-PLATE EIA | OraSure Technologies, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K972059 | QUIKPAC II ONE STEP COCAINE TEST | Drial Consultants, Inc. | 1997-08-28 | Traditional | PDF ↗ |
| K972384 | AQ ONE STEP COCAINE TEST | Bionike Laboratories, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K971926 | QUIKSTRIP ONE STEP COCAINE TEST | Drial Consultants, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964900 | RAPID DRUG SCREEN | American Bio Medica Corp. | 1997-04-14 | Traditional | PDF ↗ |
| K963918 | IMMULITE COCAINE METABOLITE | Diagnostic Products Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K962353 | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) | Princeton BioMeditech Corp. | 1996-08-19 | Traditional | PDF ↗ |
| K960187 | COCAINE METABOLITE EIA TEST | Diagnostic Reagents, Inc. | 1996-04-02 | Traditional | PDF ↗ |
| K954496 | FRONTLINE COCAINE | Boehringer Mannheim Corp. | 1996-03-06 | Traditional | PDF ↗ |
| K954571 | ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI | Princeton BioMeditech Corp. | 1995-11-03 | Traditional | PDF ↗ |
| K952361 | ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC | Princeton BioMeditech Corp. | 1995-10-26 | Traditional | PDF ↗ |
Product code DIO · Class II · Clinical Toxicology. Data: openFDA.