510(k) K243256
K243256 is an FDA 510(k) premarket notification submitted by Wondfo USA Co, Ltd. for the device "WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest". The FDA issued a decision of Substantially Equivalent on January 16, 2025. The device falls under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test), a Class II device regulated under 21 CFR 866.3987. Wondfo USA Co, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2025
- Date Received
- October 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Device Class
- Class II
- Regulation Number
- 866.3987
- Review Panel
- MI
- Submission Type
A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.