
Organon Teknika Corp.
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THROMBONOSTIKA F1.2 is an FDA 510(k)-cleared medical device (K964934) manufactured by Organon Teknika 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 March 17, 1997. Regulation: 8.