COBAS READY TOTAL BILIRUBIN REAGENT— 510(k) K896232

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K896232 for COBAS READY TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 1990-02-27. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1989-10-30
Decision date: 1990-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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