ALLERSHARP ALLERGY SKIN TESTER

ALLERSHARP ALLERGY SKIN TESTER is an FDA 510(k)-cleared medical device (K011979) manufactured by Hmb Medical Concepts, Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2001. Regulation: 8.