FDA 510(k)

URight血红蛋白A1c系统，FORA A1c系统

K号: K142664 · 2016-01-29

决定日期2016-01-29

产品代码LCP

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决定实质等同

器械摘要

URight Hemoglobin A1c system, FORA A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K142664. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the URight Hemoglobin A1c system, FORA A1c System?

URight Hemoglobin A1c system, FORA A1c System is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K142664.

When did URight Hemoglobin A1c system, FORA A1c System receive FDA 510(k) clearance?

URight Hemoglobin A1c system, FORA A1c System received FDA 510(k) clearance on 2016-01-29, under 510(k) number K142664.

Who is the listed applicant for URight Hemoglobin A1c system, FORA A1c System?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URight Hemoglobin A1c system, FORA A1c System?

The FDA product code for URight Hemoglobin A1c system, FORA A1c System is LCP.

列明Taidoc Technology Corporation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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