510(k) K910473

CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC by Coulter Immunology — Product Code GKZ

K910473 is an FDA 510(k) premarket notification submitted by Coulter Immunology for the device "CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC". The FDA issued a decision of Substantially Equivalent on October 31, 1991. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Coulter Immunology has at least 10 other 510(k) clearances on record.