
Organon Teknika Corp.
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AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 is an FDA 510(k)-cleared medical device (K944698) manufactured by Organon Teknika Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 20, 1995. Regulation: 8.