Device Classification Name |
antigens, cf (including cf control), influenza virus a, b, c
|
510(k) Number |
K133411 |
Device Name |
ALERE BINAXNOW INFLUENZA A & B CARD |
Applicant |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
10 Southgate Rd |
Scarborough,
ME
04074
|
|
Applicant Contact |
Angela Drysdale |
Correspondent |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
10 Southgate Rd |
Scarborough,
ME
04074
|
|
Correspondent Contact |
Angela Drysdale |
Regulation Number | 866.3330
|
Classification Product Code |
|
Date Received | 11/07/2013 |
Decision Date | 12/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|