OVA1 新一代
K号: K150588 · 2016-03-18
广告
决定日期2016-03-18
产品代码ONX
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
OVA1 Next Generation is the device name listed in this FDA 510(k) record. The listed applicant is Vermillion, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K150588. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OVA1 Next Generation?
OVA1 Next Generation is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Vermillion, Inc.. The 510(k) number is K150588.
When did OVA1 Next Generation receive FDA 510(k) clearance?
OVA1 Next Generation received FDA 510(k) clearance on 2016-03-18, under 510(k) number K150588.
Who is the listed applicant for OVA1 Next Generation?
The FDA 510(k) record lists Vermillion, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OVA1 Next Generation?
The FDA product code for OVA1 Next Generation is ONX.
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：ONX）
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