Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
|
510(k) Number |
K121863 |
Device Name |
VITEK 2 AST-ST CEFOTAXIME |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
ELIZABETH LANDON |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
ELIZABETH LANDON |
Regulation Number | 866.1645
|
Classification Product Code |
|
Date Received | 06/26/2012 |
Decision Date | 08/16/2012 |
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
|
|
|