STERRAD 50/100S/200 TEST PACK

STERRAD 50/100S/200 TEST PACK is an FDA 510(k)-cleared medical device (K130263) manufactured by Advanced Sterilization Products. 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 March 27, 2014. Regulation: 8.