FDA 510(k)

LC 標準流

K 號：K222445 · 2023-03-06

申請人S&C Polymer Silicon- Und Composite Spezialitaten GmbH

決定日期2023-03-06

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

LC ChromeFlow is the device name listed in this FDA 510(k) record. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitaten GmbH. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K222445. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LC ChromeFlow?

LC ChromeFlow is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitaten GmbH. The 510(k) number is K222445.

When did LC ChromeFlow receive FDA 510(k) clearance?

LC ChromeFlow received FDA 510(k) clearance on 2023-03-06, under 510(k) number K222445.

Who is the listed applicant for LC ChromeFlow?

The FDA 510(k) record lists S&C Polymer Silicon- Und Composite Spezialitaten GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LC ChromeFlow?

The FDA product code for LC ChromeFlow is EBF.

其他以 S&C Polymer Silicon- Und Composite Spezialitaten GmbH 為申請人之記錄

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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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