DOA - IMMUNOASSAY CUT-OFF CALIBRATOR

DOA - IMMUNOASSAY CUT-OFF CALIBRATOR is an FDA 510(k)-cleared medical device (K945289) manufactured by Medi-Tech, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 1994. Regulation: 8.