ENZYMUNE-TEST TSH— 510(k) K832823

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K832823 for ENZYMUNE-TEST TSH, Substantially Equivalent on 1983-10-14. Applicant: Icl Scientific.

Clearance details

Applicant: Icl Scientific
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1983-08-19
Decision date: 1983-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, 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.