PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY

PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY is an FDA 510(k)-cleared medical device (K920301) 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 25, 1994. Regulation: 8.