K243858
- 510(k) number
- K243858
- Device name
- TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- Applicant
- Haemonetics Corporation MA · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2025-01-15
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243858.pdf
Official FDA record: K243858
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.