自由濃度睪固酮AccuBind ELISA檢測系統
K 號：K181017 · 2018-07-20
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器材摘要
Free Testosterone AccuBind ELISA Test System is the device name listed in this FDA 510(k) record. The listed applicant is Monobind, Inc.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181017. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Free Testosterone AccuBind ELISA Test System?
Free Testosterone AccuBind ELISA Test System is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Monobind, Inc.. The 510(k) number is K181017.
When did Free Testosterone AccuBind ELISA Test System receive FDA 510(k) clearance?
Free Testosterone AccuBind ELISA Test System received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181017.
Who is the listed applicant for Free Testosterone AccuBind ELISA Test System?
The FDA 510(k) record lists Monobind, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Free Testosterone AccuBind ELISA Test System?
The FDA product code for Free Testosterone AccuBind ELISA Test System is CDZ.
相關臨床試驗
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相關器械（代碼：CDZ）
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。
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