K-number	K002609
Device name	TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product code	DHR
Device class	Class II
Decision date	Sep 5, 2000
Decision	Substantially Equivalent
Regulation	866.5775

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

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