ELISA TUBE TSH TEST— 510(k) K921958

Substantially Equivalent

Bio Clinic Co.

FDA 510(k) clearance K921958 for ELISA TUBE TSH TEST, Substantially Equivalent on 1992-07-02. Applicant: Bio Clinic Co..

Clearance details

Applicant: Bio Clinic Co.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1992-04-27
Decision date: 1992-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MI, US

Download summary PDF View on FDA.gov ↗

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.