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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Automated or semi-automated instrument with ultrasound-based technology. Cartridges with reagents.
Technical Method Ultrasound technology to assess coagulation characteristics of blood.
Target Area Blood
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeQFR
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5430
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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