Device Classification Name |
Devices Detecting Influenza A, B, And C Virus Antigens
|
510(k) Number |
K152870 |
Device Name |
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit |
Applicant |
BECTON DICKINSON AND CO. |
10865 ROAD TO THE CURE, SUITE 200 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
GREGORY P. PAYNE |
Correspondent |
BECTON DICKINSON AND CO. |
10865 ROAD TO THE CURE, SUITE 200 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
GREGORY P. PAYNE |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 09/30/2015 |
Decision Date | 10/27/2015 |
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
|
|
|