IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5

IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 is an FDA 510(k)-cleared medical device (K991796) 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 June 8, 1999. Regulation: 8.