IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 is an FDA 510(k)-cleared medical device (K991797) 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 June 8, 1999. Regulation: 8.