DIASTAT ANTI-HISTONE KIT— 510(k) K920616

Name: FDA 510(k) clearance K920616
Creator: U.S. Food and Drug Administration
Published: 1992-07-14

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K920616 for DIASTAT ANTI-HISTONE KIT, Substantially Equivalent on 1992-07-14. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1992-02-11
Decision date: 1992-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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