FDA 510(k)

ELITech 临床系统 BILIRUBIN TOTAL 4+1，ELITech 临床系统 BILIRUBIN DIRECT 4+1

K号: K171401 · 2017-07-11

决定日期2017-07-11

产品代码CIG

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决定实质等同

器械摘要

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K171401. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Elitechgroup. The 510(k) number is K171401.

When did ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 receive FDA 510(k) clearance?

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171401.

Who is the listed applicant for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

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

What is the FDA product code for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1?

The FDA product code for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is CIG.

列明Elitechgroup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。

K180559HSV 1 & 2 ELITe MGB 套件; ELITe InGenius K153644ELITech 临床系统 GLUCOSE HK SL，ELITech 临床系统 ELICAL 2，ELITech 临床系统 ELITROL I 和 ELITROL II

官方来源

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