Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K191953 |
Device Name |
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) |
Applicant |
BioMerieux SA |
376, Chemin de L'Orme |
Marcy L'Etoile,
FR
69280
|
|
Applicant Contact |
Marine Taravant |
Correspondent |
BioMerieux SA |
376, Chemin de L'Orme |
Marcy L'Etoile,
FR
69280
|
|
Correspondent Contact |
Marine Taravant |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 07/22/2019 |
Decision Date | 08/22/2019 |
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
|
Recalls |
CDRH Recalls
|
|
|