Home / Device Classification / LDP

LDP — Colorimetry, Acetaminophen Class II

FDA Device Classification

Classification Details

Product Code
LDP
Device Class
Class II
Regulation Number
862.3030
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202644sekisui diagnostics p.e.iAcetaminophenFebruary 18, 2022
K180835sekisui diagnostics p.e.iSEKURE Acetaminophen L3K AssayFebruary 8, 2019
K110726roche diagnosticsROCHE ACETAMINOPHEN ASSAYDecember 23, 2011
K100200siemens healthcare diagnosticsADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138August 2, 2010
K081938genzyme diagnostics p.e.iACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30May 1, 2009
K061655dade behringDIMENSION VISTA FLEX REAGENT CARTRIDGESJuly 10, 2006
K043242biosite incorporatedTRIAGE TOX DRUG SCREENFebruary 28, 2005
K042330diagnostic chemicalsACETAMINOPHEN-SL ASSAYJanuary 7, 2005
K020792bayer diagnosticsACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMJuly 11, 2002
K013757roche diagnosticsROCHE ACETAMINOPHENJanuary 8, 2002
K011465beckman coulterSYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PROJune 8, 2001
K002974dade behringEMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS,October 11, 2000
K000494beckman coulterSYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENTApril 14, 2000
K991598roche diagnosticsCOBAS INTEGRA ACETAMINOPHENJuly 22, 1999
K981059diagnostic chemicalsACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.May 12, 1998
K980031diagnostic chemicalsACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10March 3, 1998
K963244dade intlACETAMINOPHEN FLEX REAGENT CARTRIDGESeptember 23, 1996
K961373diagnostic reagentsACETAMINOPHEN SERUM TOX EIA ASSAYJuly 8, 1996
K954933johnson and johnson clinical diagnosticsEKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHENDecember 18, 1995
K952949diagnostic chemicalsACETAMINOPHEN ASSAYSeptember 6, 1995