510(k) K214002

CRYOcheck Chromogenic Factor IX by Precision Biologic, Inc. — Product Code GGP

K214002 is an FDA 510(k) premarket notification submitted by Precision Biologic, Inc. for the device "CRYOcheck Chromogenic Factor IX". The FDA issued a decision of Substantially Equivalent on December 23, 2022. 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.