K-number	K110313
Device name	TINA-QUANT HBA1C GEN.2
Applicant	Roche Diagnostics
Product code	LCP
Device class	Class II
Decision date	Dec 23, 2011
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT HBA1C GEN.2

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