BIOTROL UIBC REAGENT— 510(k) K912795

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K912795 for BIOTROL UIBC REAGENT, Substantially Equivalent on 1991-08-12. Applicant: Biotrol, USA, Inc..

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code JMO
Advisory panel: Clinical Chemistry
Date received: 1991-06-25
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westchester, PA, US

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