DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS

DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS is an FDA 510(k)-cleared medical device (K851618) manufactured by Home Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 1985. Regulation: 8.