K-number	K121610
Device name	COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
Applicant	Roche Diagnostics Operations
Product code	PDJ
Device class	Class II
Decision date	Aug 8, 2013
Decision	Substantially Equivalent
Regulation	862.1373

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View the full FDA submission: accessdata.fda.gov

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COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

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