OLYMPUS PK TP(TM) SYSTEM, MODIFICATION

OLYMPUS PK TP(TM) SYSTEM, MODIFICATION is an FDA 510(k)-cleared medical device (K911640) manufactured by Olympus Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 1991. Regulation: 8.