Atlas FDA

Atellica CH Acetaminophen 2 (ACTM)

FDA 510(k) clearance K261364 · decided 2026-07-24

Clearance details

K-number
K261364
Device name
Atellica CH Acetaminophen 2 (ACTM)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2026-04-27
Decision date
2026-07-24
Days to decision
88 days
Clearance type
Traditional
Product code
LDP
Device class
2
Regulation number
862.3030
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Acetaminophen (K202644)Sekisui Diagnostics P.E.I., Inc.2022-02-18
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DIMENSION VISTA FLEX REAGENT CARTRIDGES (K061655)Dade Behring, Inc.2006-07-10
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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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16