K936131

Substantially Equivalent

COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS

Applicant: Roche Diagnostic Systems, Inc.
Product code: LGR
Advisory panel: Clinical Toxicology
Date received: 1993-12-23
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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