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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coagulation system for the measurement of whole blood viscoelastic properties
Definition A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.
Product CodeQFR
Regulation Number 864.5430
Device Class 2


Premarket Reviews
ManufacturerDecision
HEMOSONICS, LLC
  SUBSTANTIALLY EQUIVALENT 6

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