FDA 510(k)

Progenikine 集中系統 25 mL 系統

K 號：K191564 · 2019-11-07

決定日期2019-11-07

產品代碼MUU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Emcyte Corporation 為申請人之記錄

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相關器械（代碼：MUU）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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