ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL

ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL is an FDA 510(k)-cleared medical device (K974810) manufactured by Boston Biomedica, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 1998. Regulation: 8.