Source document or public record
FDA 510(k) K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k) index record K243858. Device: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Applicant as listed: Haemonetics Corporation. Decision date: 2025-01-15.
Source
"device_name": "TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K243858.
Device name: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Applicant as listed: Haemonetics Corporation.
Decision date: 2025-01-15. Decision wording: Substantially Equivalent.
Product code: JPA. Regulation: 21 CFR 864.5425. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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