K-number	K113072
Device name	TINA-QUANT ALBUMIN GEN.2
Applicant	Roche Diagnostics Operations
Product code	DCF
Device class	Class II
Decision date	May 14, 2012
Decision	Substantially Equivalent
Regulation	866.5040

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Source

View the full FDA submission: accessdata.fda.gov

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TINA-QUANT ALBUMIN GEN.2

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