Aptima® Chlamydia trachomatis Assay
K号: K230451 · 2023-11-16
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决定日期2023-11-16
产品代码MKZ
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器械摘要
Aptima® Chlamydia trachomatis Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K230451. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aptima® Chlamydia trachomatis Assay?
Aptima® Chlamydia trachomatis Assay is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Hologic, Inc.. The 510(k) number is K230451.
When did Aptima® Chlamydia trachomatis Assay receive FDA 510(k) clearance?
Aptima® Chlamydia trachomatis Assay received FDA 510(k) clearance on 2023-11-16, under 510(k) number K230451.
Who is the listed applicant for Aptima® Chlamydia trachomatis Assay?
FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Aptima® Chlamydia trachomatis Assay?
The FDA product code for Aptima® Chlamydia trachomatis Assay is MKZ.
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Hologic, 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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