FDA 510(k)

EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgA)，EUROIMMUN 防組織轉谷氨鰐酶 ELISA (IgG)

K 號：K183313 · 2019-02-28

決定日期2019-02-28

產品代碼MVM

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-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase 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 2019-02-28 under 510(k) number K183313. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)?

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K183313.

When did EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) receive FDA 510(k) clearance?

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) received FDA 510(k) clearance on 2019-02-28, under 510(k) number K183313.

Who is the listed applicant for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase 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-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)?

The FDA product code for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) is MVM.

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。

K193115EUROIMMUN 防止-BP230-CF 適合性免疫測試 (IgG)K172582歐瑞姆免疫 IFA 粒性細胞嵌合體™ EUROPattern 及歐瑞姆免疫 EUROPLUS 粒性細胞嵌合體™ EUROPattern K172252EUROIMMUN IFA：克氏毛蟻蟻敏感（抗-dsDNA）EUROPattern K172244EUROIMMUN IFA：克氏次蟲（抗-dsDNA）EUROPattern K172722防伯氏疏螺旋体US EUROLINE-WB (IgM)K153308歐瑞姆免疫抗西尼羅病毒ELISA（IgM）

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相關器械（代碼：MVM）

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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