FDA 510(k)

TEG 6s 止血系统柠檬酸盐：K, KH, RT, FF 测定卡

K号: K243858 · 2025-01-15

决定日期2025-01-15

产品代码JPA

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决定实质等同

器械摘要

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.

常见问题

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.

列明Haemonetics Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232018Citrated: K, KH, RTH, FFH K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)K183160TEG 6s 止血系统，TEG 6s 柠檬酸盐：K, RT, FF 测定卡 K160502TEG 6s 止血系统 K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K160197Haemonetics Cell Saver Elite Autotransfusion System

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官方来源

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