COULTER CK-MB ISOENZYME REAGENT

COULTER CK-MB ISOENZYME REAGENT is an FDA 510(k)-cleared medical device (K904866) manufactured by Coulter Electronics, 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 December 12, 1990. Regulation: 8.