510(k) K023990

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 by Precision Biologic — Product Code GGP

K023990 is an FDA 510(k) premarket notification submitted by Precision Biologic for the device "CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50". The FDA issued a decision of Substantially Equivalent on March 19, 2003. 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 has at least 10 other 510(k) clearances on record.