Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K102668 |
Device Name |
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML |
Applicant |
BIOMERIEUX |
5 RUE DES AQUEDUCS |
CRAPONNE,
FR
69290
|
|
Applicant Contact |
ASA KARLSSON |
Correspondent |
BIOMERIEUX |
5 RUE DES AQUEDUCS |
CRAPONNE,
FR
69290
|
|
Correspondent Contact |
ASA KARLSSON |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 09/16/2010 |
Decision Date | 11/17/2010 |
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
|