FDA Product Code
FDA Product Code DJG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3650
510(k) Clearances — 215 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060351 | MEDTOX OXYCODONE | Medtox Diagnostics, Inc. | 2006-05-12 | Traditional | PDF ↗ |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC | Tianjin New Bay Bioresearch Co., Ltd. | 2006-04-24 | Traditional | PDF ↗ |
| K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | ACON Laboratories, Inc. | 2006-04-21 | Traditional | PDF ↗ |
| K051626 | IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS | Immunalysis Corporation | 2005-10-13 | Traditional | PDF ↗ |
| K042725 | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) | Quest Diagnostics, Inc. | 2005-07-06 | Traditional | PDF ↗ |
| K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2005-06-13 | Traditional | PDF ↗ |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-12 | Traditional | PDF ↗ |
| K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-10 | Traditional | PDF ↗ |
| K043507 | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE | ACON Laboratories, Inc. | 2005-02-25 | Traditional | PDF ↗ |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | Phamatech, Inc. | 2005-02-07 | Traditional | PDF ↗ |
| K041747 | IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) | Lifepoint,Inc | 2004-11-24 | Traditional | PDF ↗ |
| K041746 | IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) | Lifepoint,Inc | 2004-11-23 | Traditional | PDF ↗ |
| K041144 | RANDOX OPIATES ASSAY | Randox Laboratories, Ltd. | 2004-11-03 | Traditional | PDF ↗ |
| K040316 | CEDIA BUPRENORPHINE ASSAY | Microgenics Corp. | 2004-06-23 | Traditional | PDF ↗ |
| K040274 | ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE | ACON Laboratories, Inc. | 2004-05-03 | Traditional | PDF ↗ |
| K033047 | ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE | ACON Laboratories, Inc. | 2004-02-17 | Traditional | PDF ↗ |
| K031032 | VERDICT II, PROFILE II | Medtox Diagnostics, Inc. | 2003-07-14 | Special | PDF ↗ |
| K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 | Branan Medical Corp. | 2003-07-02 | Traditional | PDF ↗ |
| K031002 | SYNCHRON SYSTEMS OPIATE REAGENT | Beckman Coulter, Inc. | 2003-04-29 | Special | PDF ↗ |
| K023047 | AMEDICA DRUG SCREEN OPIATES TEST | Amedica Biotech, Inc. | 2002-11-06 | Traditional | PDF ↗ |
| K020920 | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE | Cozart Bioscience , Ltd. | 2002-11-05 | Traditional | PDF ↗ |
| K020368 | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) | Lin-Zhi International, Inc. | 2002-06-04 | Traditional | PDF ↗ |
| K020716 | RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) | Rapid Diagnostics, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K020371 | UPLINK TEST SYSTEM | OraSure Technologies, Inc. | 2002-04-03 | Traditional | PDF ↗ |
| K014101 | RAPIDONE-OXY TEST | American Bio Medica Corp. | 2002-03-20 | Traditional | PDF ↗ |
| K013314 | OPIATES | Abbott Laboratories | 2002-03-13 | Traditional | PDF ↗ |
| K013482 | ABUSCREEN ONLINE OPIATES 300 / 2000 | Roche Diagnostics Corp. | 2001-12-21 | Traditional | PDF ↗ |
| K013380 | ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE | ACON Laboratories, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K013408 | AT HOME DRUG TEST, MODEL 9079 | Phamatech, Inc. | 2001-12-06 | Special | PDF ↗ |
| K013407 | AT HOME DRUG TEST, MODEL 9084 | Phamatech, Inc. | 2001-12-06 | Special | PDF ↗ |
| K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES | Ameditech, Inc. | 2001-11-30 | Traditional | PDF ↗ |
| K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE | ACON Laboratories, Inc. | 2001-07-30 | Traditional | PDF ↗ |
| K011150 | DRIDAU OPIATE ASSAY | Microgenics Corp. | 2001-06-20 | Traditional | PDF ↗ |
| K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 | Syva Co., Dade Behring, Inc. | 2001-05-15 | Special | PDF ↗ |
| K000851 | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR | Psychemedics Corp. | 2000-12-11 | Traditional | PDF ↗ |
| K003209 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A | Dade Behring, Inc. | 2000-12-05 | Traditional | PDF ↗ |
| K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST | Branan Medical Corporation | 2000-11-27 | Traditional | PDF ↗ |
| K001178 | CEDIA DAU 6-ACETYLMORPHINE ASSAY | Microgenics Corp. | 2000-06-09 | Traditional | PDF ↗ |
| K000464 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A | Dade Behring, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K000273 | SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST | Drug Detection Devices, Ltd. | 2000-04-07 | Traditional | PDF ↗ |
| K993151 | RADID DRUG SCREEN 5-PANEL TEST | American Bio Medica Corp. | 2000-01-10 | Traditional | PDF ↗ |
| K994234 | AT HOME DRUG TEST, MODEL 9083 | Phamatech | 1999-12-30 | Special | PDF ↗ |
| K992111 | VERDICT -II OPIATES 2000 | Medtox Diagnostics, Inc. | 1999-12-16 | Traditional | PDF ↗ |
| K992890 | ROCHE COBAS INTEGRA OPIATES 300/2000 | Roche Diagnostics Corp. | 1999-11-23 | Traditional | PDF ↗ |
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | Syntron Bioresearch, Inc. | 1999-10-29 | Traditional | PDF ↗ |
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | Syntron Bioresearch, Inc. | 1999-10-29 | Traditional | PDF ↗ |
| K993165 | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 | Phamatech | 1999-10-20 | Special | PDF ↗ |
| K991883 | REDI-TEST OPIATES | Advantage Diagnostics Corp. | 1999-09-15 | Traditional | PDF ↗ |
| K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 | Princeton BioMeditech Corp. | 1999-08-10 | Special | PDF ↗ |
| K990820 | RAPIDONE - OPIATES TEST | American Bio Medica Corp. | 1999-07-15 | Traditional | PDF ↗ |
| K984152 | SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT | Beckman Coulter, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K984232 | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY | Syva Co. | 1999-01-22 | Traditional | PDF ↗ |
| K983190 | DBEST OPIATES TEST KIT | Ameritek, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | Princeton BioMeditech Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) | OraSure Technologies, Inc. | 1998-05-22 | Traditional | PDF ↗ |
| K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL | Roche Diagnostic Systems, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K973761 | MICRO-STRIP FOR OPIATE METABOLITES | Microdiagnostics, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K973156 | UBI MAGIWEL COCAINE METABOLITES | United Biotech, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES | United Biotech, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K973155 | UBI MAGIWEL OPIATE METABOLITES | United Biotech, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K972571 | QUIKSTRIP ONE STEP OPIATES TEST | Drial Consultants, Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K972619 | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) | Phamatech | 1997-08-20 | Traditional | PDF ↗ |
| K972405 | QUIKPAC II ONE STEP OPIATE TEST | Drial Consultants, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Behring Diagnostics, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K971361 | AQ OPIATES (MORPHINE) TEST | Bionike Laboratories, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K962323 | IMMULITE OPIATES SCREEN/CONTROL MODULE | Diagnostic Products Corp. | 1997-03-10 | Traditional | PDF ↗ |
| K962795 | CEDIA DAU OPIATE 2K ASSAY | Boehringer Mannheim Corp. | 1996-10-30 | Traditional | PDF ↗ |
| K954498 | FRONTLINE OPIATES | Boehringer Mannheim Corp. | 1996-03-06 | Traditional | PDF ↗ |
| K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) | Tcpi, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K935565 | OPIATES MICRO-PLATE ASSAY | Solarcare Technologies Corp,Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K951287 | AXSYM OPIATES | Abbott Laboratories | 1995-05-18 | Traditional | PDF ↗ |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K945608 | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI | Princeton BioMeditech Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K943248 | VISUALINE II MORPHINE/OPIATES/HEROIN | Sun Biomedical Laboratories, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K945343 | CEDIA DAU OPIATE ASSAY | Microgenics Corp. | 1995-01-17 | Traditional | PDF ↗ |
| K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS | Beckman-Diagnostic Systems Group | 1994-11-30 | Traditional | PDF ↗ |
| K943712 | VERDICT OPIATES | Editek, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K941041 | SOLOR CARE TECHNOLOGIES CORPORATION OPIATES | Solar Technologies Corp. | 1994-11-02 | Traditional | PDF ↗ |
| K941195 | CEDIA DAU OPIATE ASSAY | Microgenics Corp. | 1994-09-07 | Traditional | PDF ↗ |
| K935346 | CEDIA(R) DAU OPIATE ASSAY | Microgenics Corp. | 1994-01-11 | Traditional | PDF ↗ |
| K935117 | EMIT(R) IIC OPIATE ASSAY | Syva Co. | 1994-01-06 | Traditional | PDF ↗ |
| K932318 | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 | U.S. Drug Testing, Inc. | 1993-06-15 | Traditional | PDF ↗ |
| K924446 | MICRO-PLATE OPIATES ASSAY | Solarcare Technologies Corp,Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K923468 | MICRO EIA FOR OPIATE METABOLITES | Microdiagnostics, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K921328 | STC DIAGNOSTICS AUTO-LYTE OPIATE EIA | Solarcare Technologies Corp,Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K915180 | OPIATE EIA ASSAY | Diagnostic Reagents, Inc. | 1992-01-22 | Traditional | PDF ↗ |
| K913742 | IL TEST(TM) OPIATE | Instrumentation Laboratory CO | 1991-11-07 | Traditional | PDF ↗ |
| K913863 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-19 | Traditional | PDF ↗ |
| K905491 | MICROLINE SCREEN FOR OPIATES | Drug Screening Systems, Inc. | 1991-03-13 | Traditional | PDF ↗ |
| K904997 | ABUSCREEN ONLINE TM FOR OPIATES | Roche Diagnostic Systems, Inc. | 1990-12-27 | Traditional | PDF ↗ |
| K902924 | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST | Biosite Incorporated | 1990-09-14 | Traditional | PDF ↗ |
| K902577 | EMIT(R) II OPIATE ASSAY | Syva Co. | 1990-07-27 | Traditional | PDF ↗ |
| K902194 | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-07-17 | Traditional | PDF ↗ |
| K901577 | MILENIA(TM) OPIATES | Diagnostic Products Corp. | 1990-05-17 | Traditional | PDF ↗ |
| K900173 | HYCOR ACCUPINCH MORPHINE TEST | Hycor Biomedical, Inc. | 1990-03-30 | Traditional | PDF ↗ |
| K900203 | EZ-SCREEN:OPIATES | Environmental Diagnostics, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K890978 | TARGET OPIATES-R | V-Tech, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K890979 | TARGET OPIATES-V | V-Tech, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K891605 | COAT-A-COUNT(TM) FENTANYL (TKFN1) | Diagnostic Products Corp. | 1989-09-28 | Traditional | PDF ↗ |
| K890888 | ABUSCREEN FP FOR MORPHINE | Roche Diagnostic Systems, Inc. | 1989-03-15 | Traditional | PDF ↗ |
Product code DJG · Class II · Clinical Toxicology. Data: openFDA.