BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS

BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS is an FDA 510(k)-cleared medical device (K013203) manufactured by Polymer Technology Systems, 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 November 15, 2001. Regulation: 8.