QUALITROL ANA CONTROL SERUM SET

QUALITROL ANA CONTROL SERUM SET is an FDA 510(k)-cleared medical device (K961815) 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 26, 1996. Regulation: 8.