
Haemonetics Corporation
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TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge is an FDA 510(k)-cleared medical device (K183160) manufactured by Haemonetics Corporation. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 2019. Regulation: 8.