FDA 510(k)

NG-Test® CTX-M MULTI

K号: K243499 · 2025-06-04

决定日期2025-06-04

产品代码PTJ

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决定实质等同

器械摘要

NG-Test® CTX-M MULTI is the device name listed in this FDA 510(k) record. The listed applicant is Ng Biotech. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K243499. 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® CTX-M MULTI?

NG-Test® CTX-M MULTI is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Ng Biotech. The 510(k) number is K243499.

When did NG-Test® CTX-M MULTI receive FDA 510(k) clearance?

NG-Test® CTX-M MULTI received FDA 510(k) clearance on 2025-06-04, under 510(k) number K243499.

Who is the listed applicant for NG-Test® CTX-M MULTI?

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® CTX-M MULTI?

The FDA product code for NG-Test® CTX-M MULTI is PTJ.

列明Ng Biotech为申报人的其他记录

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K191889NG-Test CARBA 5

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