PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS is an FDA 510(k)-cleared medical device (K023268) manufactured by Phoenix Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2002. Regulation: 8.