COBAS READY CALIBRATOR KIT— 510(k) K897097

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K897097 for COBAS READY CALIBRATOR KIT, Substantially Equivalent on 1990-06-26. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1989-12-21
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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