Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K183160 · 2019-05-09

ApplicantHaemonetics Corporation
Decision Date2019-05-09
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge is a medical device manufactured by Haemonetics Corporation. It received FDA 510(k) clearance on 2019-05-09 under approval number K183160. 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, TEG 6s Citrated: K, RT, FF Assay Cartridge?

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by Haemonetics Corporation. The 510(k) number is K183160.

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

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge received FDA 510(k) clearance on 2019-05-09, under approval number K183160.

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

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

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

The FDA product code for TEG 6s Hemostasis System, TEG 6s Citrated: K, 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 K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) K232018Citrated: K, KH, RTH, FFH K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

View all 7 devices →

Related Devices (Code: JPA)

K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH

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.

↑