VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY— 510(k) K921816

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K921816 for VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY, Substantially Equivalent on 1992-06-18. Applicant: Biomerieux Vitek, Inc..

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1992-04-15
Decision date: 1992-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.