FDA 510(k)

EUROIMMUN 防止-BP230-CF 適合性免疫測試 (IgG)

K 號：K193115 · 2020-09-17

決定日期2020-09-17

產品代碼OEG

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

EUROIMMUN Anti-BP230-CF ELISA (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K193115. The device is classified under product code OEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EUROIMMUN Anti-BP230-CF ELISA (IgG)?

EUROIMMUN Anti-BP230-CF ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K193115.

When did EUROIMMUN Anti-BP230-CF ELISA (IgG) receive FDA 510(k) clearance?

EUROIMMUN Anti-BP230-CF ELISA (IgG) received FDA 510(k) clearance on 2020-09-17, under 510(k) number K193115.

Who is the listed applicant for EUROIMMUN Anti-BP230-CF ELISA (IgG)?

The FDA 510(k) record lists Euroimmun Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG)?

The FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG) is OEG.

其他以 Euroimmun Us, Inc. 為申請人之記錄

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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