Atellica IM CA 19-9 II— 510(k) K253528

Name: FDA 510(k) clearance K253528
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K253528 for Atellica IM CA 19-9 II, Substantially Equivalent on 2026-08-10. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code NIG
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2025-11-13
Decision date: 2026-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NIG

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K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack2023-08-09
K200997 — Lumipulse G CA19-9-N2020-05-14
K191973 — Lumpipulse G CA19-9-N2019-10-22
K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC6042011-04-06
K052889 — VITROS CA 19-92005-12-20

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K261364 — Atellica CH Acetaminophen 2 (ACTM)2026-07-24
K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)2026-02-27
K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII)2026-02-06
K251630 — Atellica IM Total PSA II (tPSAII)2026-01-05
K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)2025-12-04

Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.