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Diagnostic Products Corp.
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IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 is an FDA 510(k)-cleared medical device (K000006) manufactured by Diagnostic Products Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 2000. Regulation: 8.