DCL SYPHILIS-M CATALOG NO. 600-80

DCL SYPHILIS-M CATALOG NO. 600-80 is an FDA 510(k)-cleared medical device (K895964) manufactured by Diagnostic Chemicals, Ltd. (Usa). This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 1991. Regulation: 8.