FDA 510(k)

NG-Test CARBA 5

K-Number: K191889 · 2019-10-02

Decision Date2019-10-02

Product CodePTJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Ng Biotech as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243499NG-Test® CTX-M MULTI

Related Devices (Code: PTJ)

K243499NG-Test® CTX-M MULTINg Biotech K162385RAPIDEC CARBA NPBiomerieux S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.