視覺康-F 低紺紅素原控制血漿
K 號：K150144 · 2016-03-06
廣告
器材摘要
VisuCon-F Low Fibrinogen Control Plasma is the device name listed in this FDA 510(k) record. The listed applicant is Affinity Biologicals, Inc.. It received FDA 510(k) clearance on 2016-03-06 under 510(k) number K150144. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VisuCon-F Low Fibrinogen Control Plasma?
VisuCon-F Low Fibrinogen Control Plasma is a medical device that received FDA 510(k) clearance on 2016-03-06. The listed applicant is Affinity Biologicals, Inc.. The 510(k) number is K150144.
When did VisuCon-F Low Fibrinogen Control Plasma receive FDA 510(k) clearance?
VisuCon-F Low Fibrinogen Control Plasma received FDA 510(k) clearance on 2016-03-06, under 510(k) number K150144.
Who is the listed applicant for VisuCon-F Low Fibrinogen Control Plasma?
The FDA 510(k) record lists Affinity Biologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisuCon-F Low Fibrinogen Control Plasma?
The FDA product code for VisuCon-F Low Fibrinogen Control Plasma is GGN.
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：GGN）
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。
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