GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION is an FDA 510(k)-cleared medical device (K132272) manufactured by Glooko, 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 October 16, 2013. Regulation: 8.