K-number	K880292
Device name	FACTOR VIII REFERENCE PLASMA
Applicant	Helena Laboratories
Product code	GJT
Device class	Class II
Decision date	Feb 19, 1988
Decision	Substantially Equivalent
Regulation	864.7290

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View the full FDA submission: accessdata.fda.gov

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FACTOR VIII REFERENCE PLASMA

Everything you need for a 510(k) submission. Nothing you don't.