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FDA 510(k)

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

K-Number: K243858 · 2025-01-15

ApplicantHaemonetics Corporation
Decision Date2025-01-15
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is a medical device manufactured by Haemonetics Corporation. It received FDA 510(k) clearance on 2025-01-15 under approval number K243858. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by Haemonetics Corporation. The 510(k) number is K243858.

When was TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge approved by the FDA?

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge received FDA 510(k) clearance on 2025-01-15, under approval number K243858.

What company makes TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is manufactured by Haemonetics Corporation.

What is the FDA product code for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge?

The FDA product code for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is JPA.

Related Clinical Trials

NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT06328647 Quantra Point-of-Care Hemostasis Monitoring ACTIVE_NOT_RECRUITING NCT03836482 Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD RECRUITING NCT07495137 The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Haemonetics Corporation

K160197Haemonetics Cell Saver Elite Autotransfusion System K160502TEG 6s Hemostasis System K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) K232018Citrated: K, KH, RTH, FFH

View all 7 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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