DBEST ONE STEP OCCULT BLOOD TEST KITS

DBEST ONE STEP OCCULT BLOOD TEST KITS is an FDA 510(k)-cleared medical device (K071242) manufactured by Ameritek USA, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2008. Regulation: 8.