K063520

Substantially Equivalent

ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS

Applicant: Roche Diagnostics
Product code: OAV
Advisory panel: Clinical Toxicology
Date received: 2006-11-21
Decision date: 2007-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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