ACCESS(R) FREE T4 ASSAY— 510(k) K925913

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K925913 for ACCESS(R) FREE T4 ASSAY, Substantially Equivalent on 1993-01-27. Applicant: Bio-Rad Laboratories, Inc..

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1992-11-23
Decision date: 1993-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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.