API UNISCEPT KB/TYPE 2 AND 3

API UNISCEPT KB/TYPE 2 AND 3 is an FDA 510(k)-cleared medical device (K922926) manufactured by Analytical Products, 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 October 12, 1992. Regulation: 8.