Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K232395 |
Device Name |
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD |
Applicant |
bioMérieux |
376 Chemin de l'Orme |
Marcy-l'Etoile,
FR
69280
|
|
Applicant Contact |
Sophie Quiblier |
Correspondent |
bioMérieux |
376 Chemin de l'Orme |
Marcy-l'Etoile,
FR
69280
|
|
Correspondent Contact |
Sophie Quiblier |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 08/09/2023 |
Decision Date | 10/05/2023 |
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
|
|
|