48 HOUR BIOLOGICAL INDICATORS SPORSTRIP

48 HOUR BIOLOGICAL INDICATORS SPORSTRIP is an FDA 510(k)-cleared medical device (K841709) manufactured by Skyland Scientific Services, 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 October 1, 1984. Regulation: 8.