TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858)
Description
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge by Haemonetics Corporation, an FDA 510(k) cleared hematology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243858
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cart... | Haemonetics | 2025 |
Trace the full predicate network for K243858
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.