PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT

PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT is an FDA 510(k)-cleared medical device (K983253) manufactured by Medisense, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 1998. Regulation: 8.