OLYMPUS PK-TP ABSORBENT KIT

OLYMPUS PK-TP ABSORBENT KIT is an FDA 510(k)-cleared medical device (K905038) manufactured by Fujirebio America, 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 May 5, 1991. Regulation: 8.