K-number	DEN130002
Device name	TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Applicant	Roche Diagnostics
Product code	PDJ
Device class	Class II
Decision date	May 23, 2013
Decision	Not Substantially Equivalent
Regulation	862.1373

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT HBA1C GEN. 2 TEST SYSTEM

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