FDA 510(k)

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

K-번호: K243858 · 2025-01-15

결정일2025-01-15

제품 코드JPA

자문 위원회HE

결정Substantially Equivalent

기기 요약

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 Corporation. It received FDA 510(k) clearance on 2025-01-15 under 510(k) number K243858. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Haemonetics Corporation. The 510(k) number is K243858.

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 2025-01-15, under 510(k) number K243858.

Who is the listed applicant for TEG 6s Hemostasis System Citrated: K, KH, 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 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.

Haemonetics Corporation를 신청인으로 등재한 기타 기록

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

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