AUTOSTAT II ANA SCREEN ELISA— 510(k) K983655

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K983655 for AUTOSTAT II ANA SCREEN ELISA, Substantially Equivalent on 1999-01-28. Applicant: Cogent Diagnotics , Ltd..

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code LJM
Advisory panel: Immunology
Date received: 1998-10-19
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

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