
Diagnostic Products Corp.
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IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I is an FDA 510(k)-cleared medical device (K034055) manufactured by Diagnostic Products Corp.. 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 January 20, 2004. Regulation: 8.