K-number	K040431
Device name	ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Applicant	Roche Diagnostics Corp.
Product code	DAO
Device class	Class II
Decision date	Mar 10, 2004
Decision	Substantially Equivalent
Regulation	866.5550

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View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

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