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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
NG Biotech
Z.A. Courbouton, secteur 1, Atelier relais le Tremplin
Guipry,  FR 35480
Applicant Contact Milovan Stankov-Puges
Hardy Diagnostics
1430 West McCoy Lane
Santa Maria,  CA  93455
Correspondent Contact Anna Klavins
Regulation Number866.1640
Classification Product Code
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