ACE 赫姆oglobin A1c (HbA1c) 试剂
K 號：K170623 · 2018-02-27
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決定日期2018-02-27
產品代碼LCP
諮詢委員會HE
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決定相當於
器材摘要
ACE Hemoglobin A1c (HbA1c) Reagent is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K170623. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ACE Hemoglobin A1c (HbA1c) Reagent?
ACE Hemoglobin A1c (HbA1c) Reagent is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. The 510(k) number is K170623.
When did ACE Hemoglobin A1c (HbA1c) Reagent receive FDA 510(k) clearance?
ACE Hemoglobin A1c (HbA1c) Reagent received FDA 510(k) clearance on 2018-02-27, under 510(k) number K170623.
Who is the listed applicant for ACE Hemoglobin A1c (HbA1c) Reagent?
The FDA 510(k) record lists Alfa Wassermann Diagnostic Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent?
The FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent is LCP.
相關臨床試驗
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相關器械（代碼：LCP）
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
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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