Name: Predicase
Price: 199 USD

K-number	K033491
Device name	ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
Applicant	Roche Diagnostics Corp.
Product code	DAP
Device class	Class II
Decision date	Sep 1, 2004
Decision	Substantially Equivalent
Regulation	864.7320

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Source

View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS

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