科博斯M 511集成血液分析仪
K号: K171655 · 2018-03-02
广告
决定日期2018-03-02
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
cobas m 511 integrated hematology analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Hematology, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K171655. 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 cobas m 511 integrated hematology analyzer?
cobas m 511 integrated hematology analyzer is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Roche Diagnostics Hematology, Inc.. The 510(k) number is K171655.
When did cobas m 511 integrated hematology analyzer receive FDA 510(k) clearance?
cobas m 511 integrated hematology analyzer received FDA 510(k) clearance on 2018-03-02, under 510(k) number K171655.
Who is the listed applicant for cobas m 511 integrated hematology analyzer?
The FDA 510(k) record lists Roche Diagnostics Hematology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for cobas m 511 integrated hematology analyzer?
The FDA product code for cobas m 511 integrated 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