AUTOSTAT II ANTI-SM/RNP ELISA— 510(k) K990624

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K990624 for AUTOSTAT II ANTI-SM/RNP ELISA, Substantially Equivalent on 1999-04-28. Applicant: Cogent Diagnotics , Ltd..

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code LKO
Advisory panel: Immunology
Date received: 1999-02-25
Decision date: 1999-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

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