IMMUNOENZYME TEST SYS-DETECT-IGM ANTI

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI is an FDA 510(k)-cleared medical device (K832900) manufactured by Bionetic Laboratory Products. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 1983. Regulation: 8.