FDA 510(k)

HardyCHROM CRE

K号: K190553 · 2019-04-29

决定日期2019-04-29

产品代码JSO

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决定实质等同

器械摘要

HardyCHROM CRE is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2019-04-29 under 510(k) number K190553. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HardyCHROM CRE?

HardyCHROM CRE is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is Hardy Diagnostics. The 510(k) number is K190553.

When did HardyCHROM CRE receive FDA 510(k) clearance?

HardyCHROM CRE received FDA 510(k) clearance on 2019-04-29, under 510(k) number K190553.

Who is the listed applicant for HardyCHROM CRE?

FDA 510(k)记录显示Hardy Diagnostics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 HardyCHROM CRE?

The FDA product code for HardyCHROM CRE is JSO.

列明Hardy Diagnostics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。

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官方来源

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