API UNISCEPT MIC/UNISCEPT MICRO-MIC

API UNISCEPT MIC/UNISCEPT MICRO-MIC is an FDA 510(k)-cleared medical device (K912964) manufactured by Analytab 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 August 28, 1991. Regulation: 8.