OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT is an FDA 510(k)-cleared medical device (K984145) manufactured by Olympus Diagnostica GmbH. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 1998. Regulation: 8.