AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA— 510(k) K002215

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K002215 for AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA, Substantially Equivalent on 2000-09-28. Applicant: Cogent Diagnotics , Ltd..

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code MOB
Advisory panel: Immunology
Date received: 2000-07-24
Decision date: 2000-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian Eh26 0pl, GB

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