FDA 510(k)

Unicel DxH 800 Coulter 细胞分析系统

K号: K193124 · 2020-04-16

决定日期2020-04-16

产品代码GKZ

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决定实质等同

器械摘要

Unicel DxH 800 Coulter Cellular Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K193124. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Unicel DxH 800 Coulter Cellular Analysis System?

Unicel DxH 800 Coulter Cellular Analysis System is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Beckman Coulter. The 510(k) number is K193124.

When did Unicel DxH 800 Coulter Cellular Analysis System receive FDA 510(k) clearance?

Unicel DxH 800 Coulter Cellular Analysis System received FDA 510(k) clearance on 2020-04-16, under 510(k) number K193124.

Who is the listed applicant for Unicel DxH 800 Coulter Cellular Analysis System?

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

What is the FDA product code for Unicel DxH 800 Coulter Cellular Analysis System?

The FDA product code for Unicel DxH 800 Coulter Cellular Analysis System is GKZ.

列明Beckman Coulter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。

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