AUTOSTAT II RHEUMATOID FACTOR IGA ELISA— 510(k) K993557

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K993557 for AUTOSTAT II RHEUMATOID FACTOR IGA ELISA, Substantially Equivalent on 2000-03-03. Applicant: Cogent Diagnotics , Ltd..

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code DHR
Advisory panel: Immunology
Date received: 1999-10-20
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

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