VIDAS FREE THYROXINE(FT4) ASSAY— 510(k) K925177

Name: FDA 510(k) clearance K925177
Creator: U.S. Food and Drug Administration
Published: 1992-11-30

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K925177 for VIDAS FREE THYROXINE(FT4) ASSAY, Substantially Equivalent on 1992-11-30. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1992-10-14
Decision date: 1992-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.