SMART-READ EZTEST-STEAM SCBI AND TEST PACK

SMART-READ EZTEST-STEAM SCBI AND TEST PACK is an FDA 510(k)-cleared medical device (K093794) manufactured by Sgm Biotech, 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 May 13, 2010. Regulation: 8.