AUTOSTAT II ENA-6 PROFILE ELISA— 510(k) K003054

Name: FDA 510(k) clearance K003054
Creator: U.S. Food and Drug Administration
Published: 2000-10-13

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K003054 for AUTOSTAT II ENA-6 PROFILE ELISA, Substantially Equivalent on 2000-10-13. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-10-02
Decision date: 2000-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

Download summary PDF View on FDA.gov ↗

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