K-number	K183440
Device name	CRYOcheck FVIII Inhibitor Kit
Applicant	Precision Biologic, Inc.
Product code	GGP
Device class	Class II
Decision date	Mar 12, 2019
Decision	Substantially Equivalent
Regulation	864.7290

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Source

View the full FDA submission: accessdata.fda.gov

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CRYOcheck FVIII Inhibitor Kit

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