LYME DISEASE IGM ELISA

LYME DISEASE IGM ELISA is an FDA 510(k)-cleared medical device (K900206) manufactured by Hillcrest Biologicals. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 1991. Regulation: 8.