ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS— 510(k) K063520

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K063520 for ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS, Substantially Equivalent on 2007-02-16. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: 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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