Device Classification Name |
devices detecting influenza a, b, and c virus antigens
|
510(k) Number |
K132692 |
Device Name |
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B |
Applicant |
Becton, Dickinson and Company |
10865 ROAD TO THE CURE |
SUITE 200 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
GREGORY P PAYNE, RAC |
Correspondent |
Becton, Dickinson and Company |
10865 ROAD TO THE CURE |
SUITE 200 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
GREGORY P PAYNE, RAC |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 08/29/2013 |
Decision Date | 09/23/2013 |
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
|
|
|