OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH is an FDA 510(k)-cleared medical device (K051564) manufactured by Olympus America, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2005. Regulation: 8.