BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE is an FDA 510(k)-cleared medical device (K901054) manufactured by Bion Ent., Ltd.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 1990. Regulation: 8.