ROCHE REAGENT FOR CREATININE— 510(k) K941837

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K941837 for ROCHE REAGENT FOR CREATININE, Substantially Equivalent on 1994-08-26. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 1994-04-13
Decision date: 1994-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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