Product Code: LDP FDA class 2 21 CFR 862.3030

Colorimetry, Acetaminophen

Clinical Toxicology

Colorimetry for acetaminophen measurement is a laboratory method using colorimetric chemical reactions to quantify acetaminophen concentrations in patient specimens, commonly used in clinical toxicology to assess acetaminophen overdose and guide treatment decisions. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LDP, regulated under 21 CFR 862.3030, in the Clinical Toxicology specialty. Third-party review eligibility applies.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LDP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LDP
Device Class: FDA class 2
Regulation Number: 862.3030
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

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