Device Classification Name |
Multi-Analyte Respiratory Virus Antigen Detection Test
|
510(k) Number |
K243256 |
Device Name |
WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest |
Applicant |
Wondfo USA Co., Ltd. |
6720 Cobra Way |
San Diego,
CA
92121
|
|
Applicant Contact |
Kaiyu Xiao |
Correspondent |
Wondfo USA Co., Ltd. |
6720 Cobra Way |
San Diego,
CA
92121
|
|
Correspondent Contact |
Kaiyu Xiao |
Classification Product Code |
|
Date Received | 10/15/2024 |
Decision Date | 01/16/2025 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|