AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA— 510(k) K991890

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K991890 for AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA, Substantially Equivalent on 1999-08-09. Applicant: Cogent Diagnotics , Ltd..

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code MVJ
Advisory panel: Immunology
Date received: 1999-06-03
Decision date: 1999-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

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