FDA.report

510(k) K251024

Device
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Applicant
Haemonetics
510(k) number
K251024
Product code
JPA
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-30
Date received
2025-04-02
Regulation
864.5425
Classification name
System, Multipurpose For In Vitro Coagulation Studies
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Erica Molaro
Address
125 Summer St. Boston MA US 02110 02110

FDA Registration Numbers

Source Documents

510(k) summary PDF

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