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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
510(k) Number K191889
Device Name NG-Test CARBA 5
Applicant
Ng Biotech
Z.A. Courbouton, Secteur 1, Atelier Relais Le Tremplin
Guipry,  FR 35480
Applicant Contact Milovan Stankov-Puges
Correspondent
Hardy Diagnostics
1430 W. Mccoy Lane
Santa Monica,  CA  93455
Correspondent Contact Anna Klavins
Regulation Number866.1640
Classification Product Code
PTJ  
Date Received07/15/2019
Decision Date 10/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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