Device Classification Name |
elisa, antibody, west nile virus
|
510(k) Number |
K031953 |
Device Name |
WEST NILE VIRUS ELISA IGG, MODEL EL0300G |
Applicant |
FOCUS TECHNOLOGIES, INC. |
10703 PROGRESS WAY |
CYPRESS,
CA
90630 -4737
|
|
Applicant Contact |
MICHAEL J WAGNER |
Correspondent |
FOCUS TECHNOLOGIES, INC. |
10703 PROGRESS WAY |
CYPRESS,
CA
90630 -4737
|
|
Correspondent Contact |
MICHAEL J WAGNER |
Regulation Number | 866.3940
|
Classification Product Code |
|
Date Received | 06/25/2003 |
Decision Date | 10/22/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|