Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K000596 |
Device Name |
ETEST GATIFLOXACIN |
Applicant |
AB BIODISK |
DALVAGEN 10 |
SOLNA,
SE
16956
|
|
Applicant Contact |
ANNE BOLMSTROM |
Correspondent |
AB BIODISK |
DALVAGEN 10 |
SOLNA,
SE
16956
|
|
Correspondent Contact |
ANNE BOLMSTROM |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 02/22/2000 |
Decision Date | 05/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|