510(k) K940003

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT by Buckman Co., Inc. — Product Code GKZ

K940003 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT". The FDA issued a decision of Substantially Equivalent on October 19, 1995. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.