K910591

Substantially Equivalent

ROCHE REAGENT FOR TOTAL BILIRUBIN

Applicant: Roche Diagnostic Systems, Inc.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 1991-02-12
Decision date: 1991-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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