SERATEST ENA [SSA] KIT

SERATEST ENA [SSA] KIT is an FDA 510(k)-cleared medical device (K900617) 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 February 22, 1990. Regulation: 8.