510(k) K961807

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 by Ciba Corning Diagnostics Corp. — Product Code GLK

K961807 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4". The FDA issued a decision of Substantially Equivalent on July 26, 1996. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.