K-number	K853461
Device name	COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
Applicant	American Dade
Product code	GGP
Device class	Class II
Decision date	Aug 29, 1985
Decision	Substantially Equivalent
Regulation	864.7290

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View the full FDA submission: accessdata.fda.gov

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COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA

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