K-number	K770942
Device name	PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY
Applicant	Pharmaseal Div., Baxter Healthcare Corp.
Product code	JBQ
Device class	Class II
Decision date	Jul 21, 1977
Decision	Substantially Equivalent
Regulation	864.7060

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View the full FDA submission: accessdata.fda.gov

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PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY

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