LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203

LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 is an FDA 510(k)-cleared medical device (K984397) 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 17, 1998. Regulation: 8.