Device Classification Name |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
|
510(k) Number |
K032314 |
Device Name |
VITEK 2 GRAM POSITIVE GATIFLOXACIN |
Applicant |
BIOMERIEUX, INC. |
595 ANGLUM DR. |
HAZELWOOD,
MO
63042 -2320
|
|
Applicant Contact |
Nancy Weaver |
Correspondent |
BIOMERIEUX, INC. |
595 ANGLUM DR. |
HAZELWOOD,
MO
63042 -2320
|
|
Correspondent Contact |
Nancy Weaver |
Regulation Number | 866.1645
|
Classification Product Code |
|
Date Received | 07/28/2003 |
Decision Date | 08/22/2003 |
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
|
|
|