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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 the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2019-05-09 under 510(k) 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. The listed applicant is Haemonetics Corporation. The 510(k) number is K183160.

When did TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge receive FDA 510(k) clearance?

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

Who is the listed applicant for TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge?

The FDA 510(k) record lists Haemonetics Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Haemonetics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK232018Citrated: K, KH, RTH, FFHK221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)K160502TEG 6s Hemostasis SystemK162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

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Related Devices (Code: JPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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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