BD MAX Vaginal Panel
K号: K191957 · 2019-10-21
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决定日期2019-10-21
产品代码PQA
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器械摘要
BD MAX Vaginal Panel is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K191957. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD MAX Vaginal Panel?
BD MAX Vaginal Panel is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K191957.
When did BD MAX Vaginal Panel receive FDA 510(k) clearance?
BD MAX Vaginal Panel received FDA 510(k) clearance on 2019-10-21, under 510(k) number K191957.
Who is the listed applicant for BD MAX Vaginal Panel?
The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Diagnostics) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD MAX Vaginal Panel?
The FDA product code for BD MAX Vaginal Panel is PQA.
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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：PQA）
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。
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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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