
Organon Teknika Corp.
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FAST FORMALERT is an FDA 510(k)-cleared medical device (K853555) manufactured by Organon Teknika Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1986. Regulation: 8.