MICROMI-CK(TM)

MICROMI-CK(TM) is an FDA 510(k)-cleared medical device (K872598) manufactured by Intl. Immunoassay Laboratories, 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 August 2, 1987. Regulation: 8.