AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK— 510(k) K974027

Substantially Equivalent

Alfa Biotech (Uk) , Ltd.

FDA 510(k) clearance K974027 for AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK, Substantially Equivalent on 1998-02-02. Applicant: Alfa Biotech (Uk) , Ltd..

Clearance details

Applicant: Alfa Biotech (Uk) , Ltd.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1997-10-23
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aldershot, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.