K843824

Substantially Equivalent

COBAS FP REAGENTS FOR PHENYTOIN & CALIBR

Applicant: Roche Diagnostic Systems, Inc.
Product code: LGR
Advisory panel: Clinical Toxicology
Date received: 1984-09-28
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

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