FDA 510(k)

Quantra QStat 药盒

K号: K251404 · 2025-08-25

决定日期2025-08-25

产品代码QFR

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决定实质等同

器械摘要

Quantra QStat Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Hemosonics, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K251404. The device is classified under product code QFR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantra QStat Cartridge?

Quantra QStat Cartridge is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Hemosonics, LLC. The 510(k) number is K251404.

When did Quantra QStat Cartridge receive FDA 510(k) clearance?

Quantra QStat Cartridge received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251404.

Who is the listed applicant for Quantra QStat Cartridge?

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

What is the FDA product code for Quantra QStat Cartridge?

The FDA product code for Quantra QStat Cartridge is QFR.

列明Hemosonics, LLC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。

K240045QStat 药盒 K232215Quantra 血液凝固分析仪 K230461Quantra 血液凝固分析仪 K223433Quantra QPlus 系统 K213917QStat 药盒 K201513Quantra QPlus 系统

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官方来源

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