Device Classification Name |
devices detecting influenza a, b, and c virus antigens
|
510(k) Number |
K180438 |
Device Name |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
Applicant |
BD |
10865 Road to the Cure |
San Diego,
CA
92121
|
|
Applicant Contact |
Brad Spring |
Correspondent |
BD |
10865 Road to the Cure |
Suite 200 |
San Diego,
CA
92121
|
|
Correspondent Contact |
Mary Ann Fiechtner |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 02/20/2018 |
Decision Date | 03/20/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|