STERRAD CHEMIAL INDICATOR STRIP MODEL 14100

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 is an FDA 510(k)-cleared medical device (K111518) 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 October 2, 2012. Regulation: 8.