Lead-free Chemical Indicators for Steam Sterilization

Lead-free Chemical Indicators for Steam Sterilization is an FDA 510(k)-cleared medical device (K181788) manufactured by Kem Medical Products Corp.. 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 February 28, 2019. Regulation: 8.