ANA/LITE-HEP-2 TEST SYSTEM

ANA/LITE-HEP-2 TEST SYSTEM is an FDA 510(k)-cleared medical device (K852231) manufactured by Immuno-Products Industries. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 1985. Regulation: 8.