DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T— 510(k) K020156

Name: FDA 510(k) clearance K020156
Creator: U.S. Food and Drug Administration
Published: 2002-03-06

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K020156 for DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T, Substantially Equivalent on 2002-03-06. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Product code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2002-01-17
Decision date: 2002-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, Scotland, GB

Download summary PDF View on FDA.gov ↗

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