
Diagnostic Products Corp.
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MILENIA(TM) TOTAL IGE (MKIE1,5) is an FDA 510(k)-cleared medical device (K895004) 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 September 27, 1989. Regulation: 8.