PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS is an FDA 510(k)-cleared medical device (K881277) manufactured by Gen-Probe, 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 April 24, 1988. Regulation: 8.