510(k) K191889

Device: NG-Test CARBA 5
Applicant: NG Biotech
510(k) number: K191889
Product code: PTJ
Decision: Substantially Equivalent (SESE)
Decision date: 2019-10-02
Date received: 2019-07-15
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#

9615754
3012516784
3009963993

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
03701077400133	NG-Test CARBA 5	NG BIOTECH	2019-12-02

Other 510(k) Records For Product Code PTJ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243499	NG-Test® CTX-M MULTI	Ng Biotech	2025-06-04
K162385	RAPIDEC CARBA NP	Biomerieux S.A.	2017-04-27

Legacy Summary#

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FDA Review#

Decision Summary