DIASTAT ANTI-THYROGLOBULIN KIT— 510(k) K952183

Name: FDA 510(k) clearance K952183
Creator: U.S. Food and Drug Administration
Published: 1995-06-30

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K952183 for DIASTAT ANTI-THYROGLOBULIN KIT, Substantially Equivalent on 1995-06-30. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1995-05-09
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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