BC-5390 自動血液學分析儀
K 號：K160429 · 2016-09-01
廣告
決定日期2016-09-01
產品代碼GKZ
諮詢委員會HE
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決定相當於
器材摘要
BC-5390 Auto Hematology Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K160429. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BC-5390 Auto Hematology Analyzer?
BC-5390 Auto Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K160429.
When did BC-5390 Auto Hematology Analyzer receive FDA 510(k) clearance?
BC-5390 Auto Hematology Analyzer received FDA 510(k) clearance on 2016-09-01, under 510(k) number K160429.
Who is the listed applicant for BC-5390 Auto Hematology Analyzer?
The FDA 510(k) record lists Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BC-5390 Auto Hematology Analyzer?
The FDA product code for BC-5390 Auto Hematology Analyzer is GKZ.
相關臨床試驗
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相關器械（代碼：GKZ）
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
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