BD MAX CT/GC/TV 20-Day 质量控制板
K号: K181683 · 2018-08-28
广告
决定日期2018-08-28
产品代码PMN
咨询委员会抱歉，您提供的内容“MI”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
BD MAX CT/GC/TV 20-Day QC Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-08-28 under 510(k) number K181683. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD MAX CT/GC/TV 20-Day QC Panel?
BD MAX CT/GC/TV 20-Day QC Panel is a medical device that received FDA 510(k) clearance on 2018-08-28. The listed applicant is Microbiologics, Inc.. The 510(k) number is K181683.
When did BD MAX CT/GC/TV 20-Day QC Panel receive FDA 510(k) clearance?
BD MAX CT/GC/TV 20-Day QC Panel received FDA 510(k) clearance on 2018-08-28, under 510(k) number K181683.
Who is the listed applicant for BD MAX CT/GC/TV 20-Day QC Panel?
The FDA 510(k) record lists Microbiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD MAX CT/GC/TV 20-Day QC Panel?
The FDA product code for BD MAX CT/GC/TV 20-Day QC Panel is PMN.
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Microbiologics, 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。
相关器械（代码：PMN）
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