510(k) K183440

CRYOcheck FVIII Inhibitor Kit by Precision Biologic, Inc. — Product Code GGP

K183440 is an FDA 510(k) premarket notification submitted by Precision Biologic, Inc. for the device "CRYOcheck FVIII Inhibitor Kit". The FDA issued a decision of Substantially Equivalent on March 12, 2019. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Precision Biologic, Inc. has at least 10 other 510(k) clearances on record.