NG-Test® CTX-M MULTI
K-Number: K243499 · 2025-06-04
ApplicantNg Biotech
Decision Date2025-06-04
Product CodePTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
NG-Test® CTX-M MULTI is a medical device manufactured by Ng Biotech. It received FDA 510(k) clearance on 2025-06-04 under approval number K243499. 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® CTX-M MULTI?
NG-Test® CTX-M MULTI is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Ng Biotech. The 510(k) number is K243499.
When was NG-Test® CTX-M MULTI approved by the FDA?
NG-Test® CTX-M MULTI received FDA 510(k) clearance on 2025-06-04, under approval number K243499.
What company makes NG-Test® CTX-M MULTI?
NG-Test® CTX-M MULTI is manufactured by Ng Biotech.
What is the FDA product code for NG-Test® CTX-M MULTI?
The FDA product code for NG-Test® CTX-M MULTI is PTJ.
Other Devices by Ng Biotech
Related Devices (Code: PTJ)
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.