DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500— 510(k) K001981

Name: FDA 510(k) clearance K001981
Creator: U.S. Food and Drug Administration
Published: 2000-08-21

Substantially Equivalent

Axis-Shield , Ltd.

FDA 510(k) clearance K001981 for DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500, Substantially Equivalent on 2000-08-21. Applicant: Axis-Shield , Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield , Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2000-06-29
Decision date: 2000-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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