
Organon Teknika Corp.
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AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK is an FDA 510(k)-cleared medical device (K944697) manufactured by Organon Teknika Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 1995. Regulation: 8.