THYRO TEST— 510(k) K030912

Substantially Equivalent

Thryotec

FDA 510(k) clearance K030912 for THYRO TEST, Substantially Equivalent on 2003-07-25. Applicant: Thryotec.

Clearance details

Applicant: Thryotec
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2003-03-24
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, 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.