COBAS MIRA— 510(k) K851172

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K851172 for COBAS MIRA, Substantially Equivalent on 1985-05-02. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JJF
Advisory panel: Clinical Chemistry
Date received: 1985-03-22
Decision date: 1985-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

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