
Organon Teknika Corp.
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ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA is an FDA 510(k)-cleared medical device (K903841) 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 October 21, 1990. Regulation: 8.