AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0— 510(k) K980574

Substantially Equivalent

Alfa Biotech (Uk) , Ltd.

FDA 510(k) clearance K980574 for AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0, Substantially Equivalent on 1998-03-24. Applicant: Alfa Biotech (Uk) , Ltd..

Clearance details

Applicant: Alfa Biotech (Uk) , Ltd.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1998-02-17
Decision date: 1998-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aldershot, GB

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.