AUTOSTAT ANTI-THYROID MICROSOMAL KIT— 510(k) K925785

Name: FDA 510(k) clearance K925785
Creator: U.S. Food and Drug Administration
Published: 1993-01-21

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K925785 for AUTOSTAT ANTI-THYROID MICROSOMAL KIT, Substantially Equivalent on 1993-01-21. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1992-11-03
Decision date: 1993-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunblane, Fk15 9ep, GB

Download summary PDF View on FDA.gov ↗

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