FDA 510(k)

DIAPLUS 通用

K号: K213401 · 2022-01-31

决定日期2022-01-31

产品代码KLE

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决定实质等同

器械摘要

DIAPLUS Universal 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 2022-01-31 under 510(k) number K213401. 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 Universal?

DIAPLUS Universal is a medical device that received FDA 510(k) clearance on 2022-01-31. The listed applicant is DiaDent Group International. The 510(k) number is K213401.

When did DIAPLUS Universal receive FDA 510(k) clearance?

DIAPLUS Universal received FDA 510(k) clearance on 2022-01-31, under 510(k) number K213401.

Who is the listed applicant for DIAPLUS Universal?

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 Universal?

The FDA product code for DIAPLUS Universal 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。

K254152Dia-X Sil Light Body K254142迪亚-X 硅重体 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。