FDA 510(k)

Progenikine 浓缩系统 25 mL 系统

K号: K191564 · 2019-11-07

决定日期2019-11-07

产品代码MUU

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决定实质等同

器械摘要

Progenikine Concentrating System 25 mL System is the device name listed in this FDA 510(k) record. The listed applicant is Emcyte Corporation. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K191564. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Progenikine Concentrating System 25 mL System?

Progenikine Concentrating System 25 mL System is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Emcyte Corporation. The 510(k) number is K191564.

When did Progenikine Concentrating System 25 mL System receive FDA 510(k) clearance?

Progenikine Concentrating System 25 mL System received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191564.

Who is the listed applicant for Progenikine Concentrating System 25 mL System?

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

What is the FDA product code for Progenikine Concentrating System 25 mL System?

The FDA product code for Progenikine Concentrating System 25 mL System is MUU.

列明Emcyte 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。

K183205PureBMC 超生理学浓缩系统 30 mL 系统，PureBMC 超生理学浓缩系统 60 mL 系统，PureBMC 超生理学浓缩系统 120 mL 系统

官方来源

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