Device Classification Name |
Devices Detecting Influenza A, B, And C Virus Antigens
|
510(k) Number |
K041049 |
Device Name |
BINAXNOW INFLUENZA A & B TEST |
Applicant |
BINAX, INC. |
217 READ ST. |
PORTLAND,
ME
04103
|
|
Applicant Contact |
PAM ANGELL |
Correspondent |
BINAX, INC. |
217 READ ST. |
PORTLAND,
ME
04103
|
|
Correspondent Contact |
PAM ANGELL |
Regulation Number | 866.3328
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/2004 |
Decision Date | 08/10/2004 |
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
|
|
|