DIASTAT TOTAL ANTI-CARDIOLIPIN KIT— 510(k) K923886

Name: FDA 510(k) clearance K923886
Creator: U.S. Food and Drug Administration
Published: 1992-09-25

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K923886 for DIASTAT TOTAL ANTI-CARDIOLIPIN KIT, Substantially Equivalent on 1992-09-25. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1992-08-04
Decision date: 1992-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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