510(k) K964856

CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION by Caltag Laboratories, Inc. — Product Code GKZ

K964856 is an FDA 510(k) premarket notification submitted by Caltag Laboratories, Inc. for the device "CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION". The FDA issued a decision of Substantially Equivalent on January 17, 1997. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Caltag Laboratories, Inc. has at least 10 other 510(k) clearances on record.