AGGLUTINOTEST-C-REACTIVE PROTEIN

AGGLUTINOTEST-C-REACTIVE PROTEIN is an FDA 510(k)-cleared medical device (K791461) manufactured by Volu Sol Medical 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 December 30, 1979. Regulation: 8.