API UNISCEPT MIC 100UL

API UNISCEPT MIC 100UL is an FDA 510(k)-cleared medical device (K844159) 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 December 13, 1984. Regulation: 8.