AUTOSTAT II ANTI-SCL-70 ELISA— 510(k) K990797

Name: FDA 510(k) clearance K990797
Creator: U.S. Food and Drug Administration
Published: 1999-04-28

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K990797 for AUTOSTAT II ANTI-SCL-70 ELISA, Substantially Equivalent on 1999-04-28. 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: 1999-03-10
Decision date: 1999-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

Download summary PDF View on FDA.gov ↗

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