INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS

INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS is an FDA 510(k)-cleared medical device (K070144) manufactured by Beckman Coulter, 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 January 31, 2007. Regulation: 8.