BC-5390 自动血液分析仪
K号: K160429 · 2016-09-01
广告
决定日期2016-09-01
产品代码GKZ
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GKZ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告