FDA 510(k)

Cytomics FC 500系列（MPL或MCL）流式细胞仪

K号: K182886 · 2019-09-06

决定日期2019-09-06

产品代码GKZ

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K182886. 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 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Beckman Coulter. The 510(k) number is K182886.

When did Cytomics FC 500 Series (MPL or MCL) Flow Cytometer receive FDA 510(k) clearance?

Cytomics FC 500 Series (MPL or MCL) Flow Cytometer received FDA 510(k) clearance on 2019-09-06, under 510(k) number K182886.

Who is the listed applicant for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

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 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer?

The FDA product code for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer 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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