
Ciba Corning Diagnostics Corp.
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CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 is an FDA 510(k)-cleared medical device (K961807) manufactured by Ciba Corning Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 1996. Regulation: 8.