
Haemonetics
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TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is an FDA 510(k)-cleared medical device (K251024) manufactured by Haemonetics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2025. Regulation: 8.