HEMAGEN ENA [JO-1] KIT (EIA METHOD)

HEMAGEN ENA [JO-1] KIT (EIA METHOD) is an FDA 510(k)-cleared medical device (K915420) manufactured by Hemagen Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 1992. Regulation: 8.