PGDx elio plasma focus Dx

PGDx elio plasma focus Dx is an FDA 510(k)-cleared medical device (DEN230046) manufactured by Personal Genome Diagnostics, Inc.. This device is classified under the Pathology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2024. Regulation: 8.