K-number	K964270
Device name	UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
Applicant	Universal Reagents, Inc.
Product code	GGP
Device class	Class II
Decision date	Dec 18, 1996
Decision	Substantially Equivalent
Regulation	864.7290

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View the full FDA submission: accessdata.fda.gov

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UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA

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