SPOR-TEST PA BIOLOGICAL INDICATOR KIT

SPOR-TEST PA BIOLOGICAL INDICATOR KIT is an FDA 510(k)-cleared medical device (K050664) manufactured by Getinge USA, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2005. Regulation: 8.