K-number	K052464
Device name	TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
Applicant	Roche Diagnostics Corp.
Product code	LCP
Device class	Class II
Decision date	Sep 30, 2005
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

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