LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205

LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 is an FDA 510(k)-cleared medical device (K984473) manufactured by Bio-Rad. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1998. Regulation: 8.