510(k) K990579

CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) by Precision Biologic — Product Code GIR

K990579 is an FDA 510(k) premarket notification submitted by Precision Biologic for the device "CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)". The FDA issued a decision of Substantially Equivalent on July 23, 1999. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Precision Biologic has at least 10 other 510(k) clearances on record.