ALBUMIN COBALT BINDING TEST (ACB TEST)

ALBUMIN COBALT BINDING TEST (ACB TEST) is an FDA 510(k)-cleared medical device (K023824) manufactured by Ischemia Technologies, 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 February 13, 2003. Regulation: 8.