
W.H.P.M., Inc.
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Hemosure Accu-Reader A100 is an FDA 510(k)-cleared medical device (K200754) manufactured by W.H.P.M., 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 June 1, 2022. Regulation: 8.