BAYER ADVIA CENTAUR CA 19-9 ASSAY— 510(k) K031393

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K031393 for BAYER ADVIA CENTAUR CA 19-9 ASSAY, Substantially Equivalent on 2003-06-24. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code NIG
Advisory panel: Immunology
Date received: 2003-05-02
Decision date: 2003-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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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.