K-number	K012359
Device name	TINA-QUANT COMPLEMENT C4 TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product code	DBI
Device class	Class II
Decision date	Nov 29, 2001
Decision	Substantially Equivalent
Regulation	866.5240

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT COMPLEMENT C4 TEST SYSTEM

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