
Organon Teknika Corp.
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COAG-A-MATE - RA4 is an FDA 510(k)-cleared medical device (K900895) 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 April 15, 1990. Regulation: 8.