QUALITROL MONO CONTROL SERUM SET

QUALITROL MONO CONTROL SERUM SET is an FDA 510(k)-cleared medical device (K961550) manufactured by Consolidated Technologies, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1996. Regulation: 8.