ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is an FDA 510(k)-cleared medical device (K191807) manufactured by ALPCO. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2019. Regulation: 8.