Name: Predicase
Price: 199 USD

K-number	K981174
Device name	CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
Applicant	Precision Biologicals, Inc.
Product code	GJT
Device class	Class II
Decision date	Jan 13, 1999
Decision	Substantially Equivalent
Regulation	864.7290

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Source

View the full FDA submission: accessdata.fda.gov

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CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

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