DIASTAT ANTI-CARDIOLIPIN KIT— 510(k) K955303

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K955303 for DIASTAT ANTI-CARDIOLIPIN KIT, Substantially Equivalent on 1996-05-30. Applicant: Shield Diagnostics, Ltd..

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code MID
Advisory panel: Immunology
Date received: 1995-11-20
Decision date: 1996-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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