FDA 510(k)

DiaPlus

K号: K192392 · 2020-05-26

决定日期2020-05-26

产品代码KLE

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决定实质等同

器械摘要

DiaPlus is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K192392. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DiaPlus?

DiaPlus is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is DiaDent Group International. The 510(k) number is K192392.

When did DiaPlus receive FDA 510(k) clearance?

DiaPlus received FDA 510(k) clearance on 2020-05-26, under 510(k) number K192392.

Who is the listed applicant for DiaPlus?

FDA 510(k)记录显示DiaDent Group International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 DiaPlus?

The FDA product code for DiaPlus is KLE.

列明DiaDent Group International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。

K254142迪亚-X 硅重体 K254152Dia-X Sil Light Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流动（经济包装）；DIAFIL 大量流动（补充包装）；DIAFIL 大量流动（0.5g）K254112Dia-X Sil Bite

查看所有 23 个设备 →

官方来源

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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。