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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K251024
Device Name TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Applicant
Haemonetics
125 Summer St.
Boston,  MA  02110
Applicant Contact Erica Molaro
Correspondent
Haemonetics
125 Summer St.
Boston,  MA  02110
Correspondent Contact Erica Molaro
Regulation Number864.5425
Classification Product Code
JPA  
Date Received04/02/2025
Decision Date 04/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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