Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K192050 |
Device Name |
ETEST Eravacycline (ERV) (0.002 – 32 µg/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 | 07/31/2019 |
Decision Date | 09/27/2019 |
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
|