K-number	K091916
Device name	INNOVANCE D-DIMER, MODEL OPBP09
Applicant	Siemens Healthcare Diagnostics
Product code	DAP
Device class	Class II
Decision date	Oct 29, 2009
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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INNOVANCE D-DIMER, MODEL OPBP09

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