QUANTA PLEX ENA PROFILE 6

QUANTA PLEX ENA PROFILE 6 is an FDA 510(k)-cleared medical device (K031450) manufactured by Inova Diagnostics, 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 June 24, 2003. Regulation: 8.