
Microgenics Corp.
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THERMO SCIENTIFIC CYTO-CAL COUNT TUBES is an FDA 510(k)-cleared medical device (K090810) manufactured by Microgenics 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 September 17, 2009. Regulation: 8.