Device Classification Name |
Devices Detecting Influenza A, B, And C Virus Antigens
|
510(k) Number |
K223016 |
Device Name |
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit |
Applicant |
BD |
7 Loveton Cir |
Sparks,
MD
21152
|
|
Applicant Contact |
Dung Nguyen |
Correspondent |
BD |
7 Loveton Cir |
Sparks,
MD
21152
|
|
Correspondent Contact |
Dung Nguyen |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 09/29/2022 |
Decision Date | 01/27/2023 |
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
|
|
|