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510(k) K261364

Device
Atellica CH Acetaminophen 2 (ACTM)
Applicant
Siemens Healthcare Diagnostics, Inc.
510(k) number
K261364
Product code
LDP
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-24
Date received
2026-04-27
Regulation
862.3030
Classification name
Colorimetry, Acetaminophen
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Kelly Maher
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LDP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.2022-02-18
K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.2019-02-08
K110726ROCHE ACETAMINOPHEN ASSAYRoche Diagnostics2011-12-23
K100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare Diagnostics2010-08-02
K081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.2009-05-01
K061655DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10
K043242TRIAGE TOX DRUG SCREENBiosite Incorporated2005-02-28
K042330ACETAMINOPHEN-SL ASSAYDiagnostic Chemicals , Ltd.2005-01-07
K020792ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.2002-07-11
K013757ROCHE ACETAMINOPHENRoche Diagnostics Corp.2002-01-08
K011465SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PROBeckman Coulter, Inc.2001-06-08
K002974EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409ULDade Behring, Inc.2000-10-11
K000494SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENTBeckman Coulter, Inc.2000-04-14
K991598COBAS INTEGRA ACETAMINOPHENRoche Diagnostics Corp.1999-07-22
K981059ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.Diagnostic Chemicals , Ltd.1998-05-12