
Chromogenix AB
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COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S is an FDA 510(k)-cleared medical device (K963111) manufactured by Chromogenix AB. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 1996. Regulation: 8.