Panels › Clinical Toxicology › Product code LDP · Class 2
Colorimetry, Acetaminophen
Regulation 862.3030
1510(k)s in 12 months (37 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in LDP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K261364 | Atellica CH Acetaminophen 2 (ACTM) Siemens Healthcare Diagnostics, Inc. | LDP |
| Feb 18, 2022 | K202644 | Acetaminophen Sekisui Diagnostics P.E.I., Inc., CA | LDP |
| Feb 8, 2019 | K180835 | SEKURE Acetaminophen L3K Assay Sekisui Diagnostics P.E.I., Inc., CA | LDP |
| Dec 23, 2011 | K110726 | ROCHE ACETAMINOPHEN ASSAY Roche Diagnostics | LDP |
| Aug 2, 2010 | K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 Siemens Healthcare Diagnostics | LDP |
| May 1, 2009 | K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 Genzyme Diagnostics P.E.I., Inc., CA | LDP |
| Jul 10, 2006 | K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES Dade Behring, Inc. | LDP |
| Feb 28, 2005 | K043242 | TRIAGE TOX DRUG SCREEN Biosite Incorporated | LDP |
| Jan 7, 2005 | K042330 | ACETAMINOPHEN-SL ASSAY Diagnostic Chemicals , Ltd., CA | LDP |
| Jul 11, 2002 | K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | LDP |
| Jan 8, 2002 | K013757 | ROCHE ACETAMINOPHEN Roche Diagnostics Corp. | LDP |
| Jun 8, 2001 | K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO Beckman Coulter, Inc. | LDP |
| Oct 11, 2000 | K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL Dade Behring, Inc. | LDP |
| Apr 14, 2000 | K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT Beckman Coulter, Inc. | LDP |
| Jul 22, 1999 | K991598 | COBAS INTEGRA ACETAMINOPHEN Roche Diagnostics Corp. | LDP |
| May 12, 1998 | K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. Diagnostic Chemicals , Ltd., CA | LDP |
| Mar 3, 1998 | K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 Diagnostic Chemicals , Ltd., CA | LDP |
| Sep 23, 1996 | K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LDP |
| Jul 8, 1996 | K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY Diagnostic Reagents, Inc. | LDP |
| Dec 18, 1995 | K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN Johnson & Johnson Clinical Diagnostics, Inc. | LDP |
| Sep 6, 1995 | K952949 | ACETAMINOPHEN ASSAY Diagnostic Chemicals , Ltd., CA | LDP |
| Aug 24, 1995 | K953094 | AXSYM ACETAMINOPHEN Abbott Laboratories | LDP |
| Jul 8, 1993 | K931257 | ACETASITE Gds Diagnostics | LDP |
| May 10, 1990 | K897118 | SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM Medisense, Inc. | LDP |
| Jan 11, 1989 | K885097 | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 Diagnostic Chemicals, Ltd. (Usa) | LDP |
| Aug 8, 1988 | K882719 | EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 Em Diagnostic Systems, Inc. | LDP |
| May 27, 1988 | K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT Gds Technology, LLC | LDP |
| Apr 17, 1985 | K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 Stanbio Laboratory | LDP |
| Jan 18, 1985 | K844962 | EMIT QST ACETAMINOPHEN ASSAY Syva Co. | LDP |
| Aug 16, 1984 | K842548 | ACA ACETAMINOPHEN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | LDP |
| May 11, 1984 | K840941 | TDX ACETAMINOPHEN Abbott Laboratories | LDP |
| Oct 4, 1983 | K832045 | ACETAMINOPHER ASSAY KIT Quantimetrix Corp. | LDP |
| Sep 12, 1983 | K832567 | ACETAMINOPHEN(PARACETAMOL Bio-Analytics Laboratories, Inc. | LDP |
| Aug 24, 1982 | K822313 | PROCEDURE #430 & REAGENTS FOR ACETAMIN Sigma Chemical Co. | LDP |
| Jul 16, 1982 | K821969 | ACETAMINOPHEN STAT-PAK REAGENT SET Clin Tech Diagnostics Corp. | LDP |
| May 28, 1982 | K821379 | EMIT-TOX ACETAMINOPHEN ASSAY Syva Co. | LDP |
| Jun 20, 1980 | K801014 | STANBIO ACETAMINOPHEN TEST SET #0850 Stanbio Laboratory | LDP |
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