Atlas FDA

LDP

37 FDA 510(k) clearances · Product code

57 daysmedian time to decision
282 days90th percentile
37clearances measured

FDA profile

Official device name
Colorimetry, Acetaminophen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3030
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 6 · 2010: 5 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Atellica CH Acetaminophen 2 (ACTM) (K261364)Siemens Healthcare Diagnostics, Inc.2026-07-24
Acetaminophen (K202644)Sekisui Diagnostics P.E.I., Inc.2022-02-18
SEKURE Acetaminophen L3K Assay (K180835)Sekisui Diagnostics P.E.I., Inc.2019-02-08
ROCHE ACETAMINOPHEN ASSAY (K110726)Roche Diagnostics2011-12-23
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (K100200)Siemens Healthcare Diagnostics2010-08-02
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (K081938)Genzyme Diagnostics P.E.I., Inc.2009-05-01
DIMENSION VISTA FLEX REAGENT CARTRIDGES (K061655)Dade Behring, Inc.2006-07-10
TRIAGE TOX DRUG SCREEN (K043242)Biosite Incorporated2005-02-28
ACETAMINOPHEN-SL ASSAY (K042330)Diagnostic Chemicals , Ltd.2005-01-07
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020792)Bayer Diagnostics Corp.2002-07-11
ROCHE ACETAMINOPHEN (K013757)Roche Diagnostics Corp.2002-01-08
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (K011465)Beckman Coulter, Inc.2001-06-08
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL (K002974)Dade Behring, Inc.2000-10-11
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT (K000494)Beckman Coulter, Inc.2000-04-14
COBAS INTEGRA ACETAMINOPHEN (K991598)Roche Diagnostics Corp.1999-07-22
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. (K981059)Diagnostic Chemicals , Ltd.1998-05-12
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 (K980031)Diagnostic Chemicals , Ltd.1998-03-03
ACETAMINOPHEN FLEX REAGENT CARTRIDGE (K963244)Dade Intl., Inc.1996-09-23
ACETAMINOPHEN SERUM TOX EIA ASSAY (K961373)Diagnostic Reagents, Inc.1996-07-08
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN (K954933)Johnson & Johnson Clinical Diagnostics, Inc.1995-12-18
ACETAMINOPHEN ASSAY (K952949)Diagnostic Chemicals , Ltd.1995-09-06
AXSYM ACETAMINOPHEN (K953094)Abbott Laboratories1995-08-24
ACETASITE (K931257)Gds Diagnostics1993-07-08
SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM (K897118)Medisense, Inc.1990-05-10
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 (K885097)Diagnostic Chemicals, Ltd. (Usa)1989-01-11
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 (K882719)Em Diagnostic Systems, Inc.1988-08-08
GDS ENZYMATIC ACETAMINOPHEN REAGENT (K880829)Gds Technology, LLC1988-05-27
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 (K851278)Stanbio Laboratory1985-04-17
EMIT QST ACETAMINOPHEN ASSAY (K844962)Syva Co.1985-01-18
ACA ACETAMINOPHEN ANALYTICAL TEST PACK (K842548)E.I. Dupont DE Nemours & Co., Inc.1984-08-16
TDX ACETAMINOPHEN (K840941)Abbott Laboratories1984-05-11
ACETAMINOPHER ASSAY KIT (K832045)Quantimetrix Corp.1983-10-04
ACETAMINOPHEN(PARACETAMOL (K832567)Bio-Analytics Laboratories, Inc.1983-09-12
PROCEDURE #430 & REAGENTS FOR ACETAMIN (K822313)Sigma Chemical Co.1982-08-24
ACETAMINOPHEN STAT-PAK REAGENT SET (K821969)Clin Tech Diagnostics Corp.1982-07-16
EMIT-TOX ACETAMINOPHEN ASSAY (K821379)Syva Co.1982-05-28
STANBIO ACETAMINOPHEN TEST SET #0850 (K801014)Stanbio Laboratory1980-06-20

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Every clearance here is in the API, with alerts when new ones post.