VITROS XT 化学产品 尿素-肌酐试纸
K号: K190326 · 2019-03-14
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决定日期2019-03-14
产品代码CDN
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
VITROS XT Chemistry Products UREA-CREA Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190326. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VITROS XT Chemistry Products UREA-CREA Slides?
VITROS XT Chemistry Products UREA-CREA Slides is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190326.
When did VITROS XT Chemistry Products UREA-CREA Slides receive FDA 510(k) clearance?
VITROS XT Chemistry Products UREA-CREA Slides received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190326.
Who is the listed applicant for VITROS XT Chemistry Products UREA-CREA Slides?
The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VITROS XT Chemistry Products UREA-CREA Slides?
The FDA product code for VITROS XT Chemistry Products UREA-CREA Slides is CDN.
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。
列明Ortho-Clinical Diagnostics, Inc.为申报人的其他记录
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。
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