Anti-Borrelia burgdorferi US 西方免疫印迹 (IgG)
K 號：K161513 · 2016-08-25
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器材摘要
Anti-Borrelia burgdorferi US Westernblot (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun US. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161513. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Anti-Borrelia burgdorferi US Westernblot (IgG)?
Anti-Borrelia burgdorferi US Westernblot (IgG) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Euroimmun US. The 510(k) number is K161513.
When did Anti-Borrelia burgdorferi US Westernblot (IgG) receive FDA 510(k) clearance?
Anti-Borrelia burgdorferi US Westernblot (IgG) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161513.
Who is the listed applicant for Anti-Borrelia burgdorferi US Westernblot (IgG)?
The FDA 510(k) record lists Euroimmun US as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG)?
The FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG) is LSR.
相關臨床試驗
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。
相關器械（代碼：LSR）
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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