K953528

Substantially Equivalent

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN

Applicant: Roche Diagnostic Systems, Inc.
Product code: LEH
Advisory panel: Clinical Toxicology
Date received: 1995-07-27
Decision date: 1995-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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