FDA 510(k)

NG-Test CARBA 5

K号: K191889 · 2019-10-02

决定日期2019-10-02

产品代码PTJ

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决定实质等同

器械摘要

NG-Test CARBA 5 is the device name listed in this FDA 510(k) record. The listed applicant is Ng Biotech. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191889. The device is classified under product code PTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NG-Test CARBA 5?

NG-Test CARBA 5 is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Ng Biotech. The 510(k) number is K191889.

When did NG-Test CARBA 5 receive FDA 510(k) clearance?

NG-Test CARBA 5 received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191889.

Who is the listed applicant for NG-Test CARBA 5?

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

What is the FDA product code for NG-Test CARBA 5?

The FDA product code for NG-Test CARBA 5 is PTJ.

列明Ng Biotech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。

K243499NG-Test® CTX-M MULTI

官方来源

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