TEG 6s Hemostasis System, Citrated: K, RT, FF Assay Cartridge
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183160 FDA 510(k)
- FDA Product Code
- JPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TEG 6s Hemostasis System is a multipurpose in vitro coagulation testing device designed for hemostasis assessment. It provides semi-quantitative evaluations of venous blood samples using viscoelastic testing principles to analyze clot formation, strength, and lysis. The Citrated: K, RT, FF Assay Cartridge enables four independent assays (K, KH, RT, FF) to assess intrinsic pathway function and platelet activity. This system supports clinical decision-making in hematology and perioperative care.
The TEG 6s Hemostasis System is intended for use in clinical laboratories and perioperative settings, requiring venous blood samples collected in citrated tubes. The Citrated: K, RT, FF Assay Cartridge is single-use and designed for compatibility with the TEG 6s analyzer. The device is classified as Class II under FDA regulations (510(k) clearance K183160) and adheres to regulatory standards for in vitro diagnostic use. Storage and handling follow manufacturer guidelines to maintain assay integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TEG® 6s | Haemonetics® Hospital Solutions, TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge ..., TEG 6s Hemostasis Analyzer System | Haemonetics Hospital Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183160 | Class II | Active |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
Sources (1)
- FDA 510(k) K183160 24 fields · synced Oct 1, 2026