RADIAS FREE T4 ENZYME IMMUNOASSAY— 510(k) K931110

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K931110 for RADIAS FREE T4 ENZYME IMMUNOASSAY, Substantially Equivalent on 1993-05-20. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1993-03-03
Decision date: 1993-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

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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.