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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
510(k) Number K251404
Device Name Quantra QStat Cartridge
Applicant
Hemosonics, LLC
4020 Stirrup Creek Dr.
Suite 105
Durham,  NC  27703
Applicant Contact Garrett Sparks
Correspondent
Hemosonics, LLC
4020 Stirrup Creek Dr.
Suite 105
Durham,  NC  27703
Correspondent Contact Garrett Sparks
Classification Product Code
QFR  
Date Received05/06/2025
Decision Date 08/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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