
Immunostics Inc.,
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AFIAS iFOB with AFIAS-50 is an FDA 510(k)-cleared medical device (K163225) manufactured by Immunostics Inc.,. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2017. Regulation: 8.