MODIFIED UNISCEPT KB LABELING AMENDMENT

MODIFIED UNISCEPT KB LABELING AMENDMENT is an FDA 510(k)-cleared medical device (K861408) 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 May 15, 1986. Regulation: 8.