510(k) K944127

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY by Caltag Laboratories, Inc. — Product Code GKZ

K944127 is an FDA 510(k) premarket notification submitted by Caltag Laboratories, Inc. for the device "CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on June 20, 1995. 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.