ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP is an FDA 510(k)-cleared medical device (K922136) 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 9, 1993. Regulation: 8.