Device Classification Name |
devices detecting influenza a, b, and c virus antigens
|
510(k) Number |
K062109 |
Device Name |
BINAXNOW INFLUENZA A & B TEST |
Applicant |
BINAX, INC. |
10 SOUTHGATE RD. |
SCARBOROUGH,
ME
04074
|
|
Applicant Contact |
Angela Drysdale |
Correspondent |
BINAX, INC. |
10 SOUTHGATE RD. |
SCARBOROUGH,
ME
04074
|
|
Correspondent Contact |
Angela Drysdale |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 07/24/2006 |
Decision Date | 11/09/2006 |
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
|
|
|