K-number	K033612
Device name	FACTOR II (PROTHROMBIN) G20210A KIT
Applicant	Roche Diagnostics Corp.
Product code	NPR
Device class	Class II
Decision date	Dec 18, 2003
Decision	Substantially Equivalent
Regulation	864.7280

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Source

View the full FDA submission: accessdata.fda.gov

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FACTOR II (PROTHROMBIN) G20210A KIT

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