FDA.reportPublic FDA data

510(k) K243499

Device
NG-Test® CTX-M MULTI
Applicant
Ng Biotech
510(k) number
K243499
Product code
PTJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-04
Date received
2024-11-12
Regulation
866.1640
Classification name
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Milovan Stankov-Puges
Address
Z.A. Courbouton, Secteur 1, Atelier Relais Le Tremplin Guipry FR 35480 35480

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PTJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191889NG-Test CARBA 5Ng Biotech2019-10-02
K162385RAPIDEC CARBA NPBiomerieux S.A.2017-04-27