COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 is an FDA 510(k)-cleared medical device (K901859) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 1990. Regulation: 8.