FDA 510(k)

DxH 520血液分析仪

K号: K181475 · 2019-03-01

决定日期2019-03-01

产品代码GKZ

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决定Unknown

器械摘要

DxH 520 Hematology Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K181475. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

常见问题

What is the DxH 520 Hematology Instrument?

DxH 520 Hematology Instrument is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Beckman Coulter. The 510(k) number is K181475.

When did DxH 520 Hematology Instrument receive FDA 510(k) clearance?

DxH 520 Hematology Instrument received FDA 510(k) clearance on 2019-03-01, under 510(k) number K181475.

Who is the listed applicant for DxH 520 Hematology Instrument?

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 DxH 520 Hematology Instrument?

The FDA product code for DxH 520 Hematology Instrument 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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