FDA Product Code
FDA Product Code LDP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3030
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 | Traditional | PDF ↗ |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 | Traditional | PDF ↗ |
| K110726 | ROCHE ACETAMINOPHEN ASSAY | Roche Diagnostics | 2011-12-23 | Traditional | PDF ↗ |
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | 2010-08-02 | Traditional | PDF ↗ |
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009-05-01 | Traditional | PDF ↗ |
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | 2006-07-10 | Special | PDF ↗ |
| K043242 | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | 2005-02-28 | Traditional | PDF ↗ |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | 2005-01-07 | Traditional | PDF ↗ |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 | Traditional | PDF ↗ |
| K013757 | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | 2002-01-08 | Traditional | PDF ↗ |
| K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | Beckman Coulter, Inc. | 2001-06-08 | Special | PDF ↗ |
| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | 1999-07-22 | Traditional | PDF ↗ |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 | Traditional | PDF ↗ |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | 1998-03-03 | Traditional | PDF ↗ |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-23 | Traditional | PDF ↗ |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K952949 | ACETAMINOPHEN ASSAY | Diagnostic Chemicals , Ltd. | 1995-09-06 | Traditional | PDF ↗ |
| K953094 | AXSYM ACETAMINOPHEN | Abbott Laboratories | 1995-08-24 | Traditional | PDF ↗ |
| K931257 | ACETASITE | Gds Diagnostics | 1993-07-08 | Traditional | PDF ↗ |
| K897118 | SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM | Medisense, Inc. | 1990-05-10 | Traditional | PDF ↗ |
| K885097 | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 | Diagnostic Chemicals, Ltd. (Usa) | 1989-01-11 | Traditional | PDF ↗ |
| K882719 | EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 | Em Diagnostic Systems, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | Gds Technology, LLC | 1988-05-27 | Traditional | PDF ↗ |
| K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 | Stanbio Laboratory | 1985-04-17 | Traditional | PDF ↗ |
| K844962 | EMIT QST ACETAMINOPHEN ASSAY | Syva Co. | 1985-01-18 | Traditional | PDF ↗ |
| K842548 | ACA ACETAMINOPHEN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K840941 | TDX ACETAMINOPHEN | Abbott Laboratories | 1984-05-11 | Traditional | PDF ↗ |
| K832045 | ACETAMINOPHER ASSAY KIT | Quantimetrix Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Bio-Analytics Laboratories, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K822313 | PROCEDURE #430 & REAGENTS FOR ACETAMIN | Sigma Chemical Co. | 1982-08-24 | Traditional | PDF ↗ |
| K821969 | ACETAMINOPHEN STAT-PAK REAGENT SET | Clin Tech Diagnostics Corp. | 1982-07-16 | Traditional | PDF ↗ |
| K821379 | EMIT-TOX ACETAMINOPHEN ASSAY | Syva Co. | 1982-05-28 | Traditional | PDF ↗ |
| K801014 | STANBIO ACETAMINOPHEN TEST SET #0850 | Stanbio Laboratory | 1980-06-20 | Traditional | PDF ↗ |
Product code LDP · Class II · Clinical Toxicology. Data: openFDA.