
Diagnostic Products Corp.
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IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) is an FDA 510(k)-cleared medical device (K012301) 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 September 18, 2001. Regulation: 8.