SYPHILIS IGM HUMAN SERUM CONTROLS

SYPHILIS IGM HUMAN SERUM CONTROLS is an FDA 510(k)-cleared medical device (K961317) manufactured by Pyramid Biological Corp.. 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 23, 1996. Regulation: 8.