COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR— 510(k) K942847

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K942847 for COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR, Substantially Equivalent on 1994-12-02. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LAR
Advisory panel: Clinical Toxicology
Date received: 1994-06-16
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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