AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501— 510(k) K974505

Name: FDA 510(k) clearance K974505
Creator: U.S. Food and Drug Administration
Published: 1998-02-17

Substantially Equivalent

Alfa Biotech (Uk) , Ltd.

FDA 510(k) clearance K974505 for AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501, Substantially Equivalent on 1998-02-17. Applicant: Alfa Biotech (Uk) , Ltd.. Device class: 2.

Clearance details

Applicant: Alfa Biotech (Uk) , Ltd.
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1997-12-01
Decision date: 1998-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aldershot Hants, GB

Download summary PDF View on FDA.gov ↗

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