ALFIS Vitamin D, ALFIS-3 Analyzer

ALFIS Vitamin D, ALFIS-3 Analyzer is an FDA 510(k)-cleared medical device (K221817) manufactured by Immunostics Inc.,. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2023. Regulation: 8.