COBAS CALIBRATOR SERUM— 510(k) K850859

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K850859 for COBAS CALIBRATOR SERUM, Substantially Equivalent on 1985-05-10. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1985-03-01
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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