OLYMPUS PK(TM) TP

OLYMPUS PK(TM) TP is an FDA 510(k)-cleared medical device (K893124) manufactured by Fujirebio Diagnostics,Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 1989. Regulation: 8.