K121610

Substantially Equivalent

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

Applicant: Roche Diagnostics Operations
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2012-06-01
Decision date: 2013-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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