510(k) K060423

CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES by Dakocytomation California, Inc. — Product Code GKZ

K060423 is an FDA 510(k) premarket notification submitted by Dakocytomation California, Inc. for the device "CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES". The FDA issued a decision of Substantially Equivalent on August 15, 2006. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Dakocytomation California, Inc. has at least 1 other 510(k) clearance on record.