ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY is an FDA 510(k)-cleared medical device (K071587) manufactured by Inverness Medical Innovations, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 29, 2007. Regulation: 8.