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Hemosonics, LLC
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Quantra Hemostasis Analyzer, QPlus Cartridge is an FDA 510(k)-cleared medical device (DEN180017) manufactured by Hemosonics, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2019. Regulation: 8.