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FDA 510(k)

NG-Test CARBA 5

K-Number: K191889 · 2019-10-02

ApplicantNg Biotech
Decision Date2019-10-02
Product CodePTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NG-Test CARBA 5 is a medical device manufactured by Ng Biotech. It received FDA 510(k) clearance on 2019-10-02 under approval 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. It is manufactured by Ng Biotech. The 510(k) number is K191889.

When was NG-Test CARBA 5 approved by the FDA?

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

What company makes NG-Test CARBA 5?

NG-Test CARBA 5 is manufactured by Ng Biotech.

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

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

Other Devices by Ng Biotech

K243499NG-Test® CTX-M MULTI

Related Devices (Code: PTJ)

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

Official Source

View on FDA Database →

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

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