GENSTRIP TEST STRIP MODEL 100-201

GENSTRIP TEST STRIP MODEL 100-201 is an FDA 510(k)-cleared medical device (K103542) manufactured by Shasta Technologies, LLC. 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 29, 2012. Regulation: 8.