Name: Predicase
Price: 199 USD

K-number	K002706
Device name	ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
Applicant	Roche Diagnostics Corp.
Product code	DAP
Device class	Class II
Decision date	Mar 16, 2001
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

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