FDA 510(k)

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM 適體抗體ELISA檢測套件

K 號：K203289 · 2021-03-22

決定日期2021-03-22

產品代碼LSR

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Diagnostics. It received FDA 510(k) clearance on 2021-03-22 under 510(k) number K203289. 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 Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit?

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K203289.

When did Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit receive FDA 510(k) clearance?

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203289.

Who is the listed applicant for Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit?

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

What is the FDA product code for Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit?

The FDA product code for Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit is LSR.

其他以 Gold Standard Diagnostics 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。

K203296Gold Standard Diagnostics 摩氏疏螺旋體IgG ELISA檢測套件 K203292Gold Standard Diagnostics 摩氏疏螺旋體IgG/IgM ELISA檢測套件 K203295Gold Standard Diagnostics 摩氏疏螺旋體IgM ELISA檢測套件 K200025Gold Standard Diagnostics 摩氏疏螺旋體IgG ELISA檢測套件 K200023Gold Standard Diagnostics 摩氏疏螺旋體IgM ELISA檢測套件 K180264Gold Standard Diagnostics 摩氏疏螺旋體IgG/IgM ELISA檢測套件

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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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