ROCHE REAGENT FOR AMMONIA— 510(k) K913124

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K913124 for ROCHE REAGENT FOR AMMONIA, Substantially Equivalent on 1991-08-12. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIF
Advisory panel: Clinical Chemistry
Date received: 1991-07-15
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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