COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS— 510(k) K852318

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K852318 for COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS, Substantially Equivalent on 1985-06-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LFT
Advisory panel: Clinical Toxicology
Date received: 1985-05-31
Decision date: 1985-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

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