FDA 510(k)

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

Номер K: K251024 · 2025-04-30

ЗаявительHaemonetics

Дата решения2025-04-30

Код продуктаJPA

Консультативный комитетHE

РешениеSubstantially Equivalent

Описание устройства

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K251024. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

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 2025-04-30. The listed applicant is Haemonetics. The 510(k) number is K251024.

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

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge received FDA 510(k) clearance on 2025-04-30, under 510(k) number K251024.

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

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

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JPA)

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation K233790ACL TOP 970 CLInstrumentation Laboratory K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO

Официальный источник

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