510(k) K962768

CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL by Coulter Corp. — Product Code GKZ

K962768 is an FDA 510(k) premarket notification submitted by Coulter Corp. for the device "CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL". The FDA issued a decision of Substantially Equivalent on January 6, 1997. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Coulter Corp. has at least 10 other 510(k) clearances on record.