EntericBio Dx 檢測試劑
K 號：K182703 · 2019-06-19
廣告
器材摘要
EntericBio Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182703. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EntericBio Dx Assay?
EntericBio Dx Assay is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Serosep , Ltd.. The 510(k) number is K182703.
When did EntericBio Dx Assay receive FDA 510(k) clearance?
EntericBio Dx Assay received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182703.
Who is the listed applicant for EntericBio Dx Assay?
The FDA 510(k) record lists Serosep , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EntericBio Dx Assay?
The FDA product code for EntericBio Dx Assay is PCH.
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：PCH）
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。
K253722LIAISON PLEX 消化道柔軟性試驗Luminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993山貓融合內分泌系統廣範細菌試驗Hologic, Inc.K251868山貓融合胃腸細菌試驗Hologic
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告