DIASTAT ANTI-CENTROMERE KIT— 510(k) K932877

Name: FDA 510(k) clearance K932877
Creator: U.S. Food and Drug Administration
Published: 1993-10-15

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K932877 for DIASTAT ANTI-CENTROMERE KIT, Substantially Equivalent on 1993-10-15. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1993-06-14
Decision date: 1993-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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