510(k) K230828
K230828 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Flowflex COVID-19 Antigen Home Test". The FDA issued a decision of Substantially Equivalent on November 9, 2023. The device falls under product code QYT (Over-The-Counter Covid-19 Antigen Test), a Class II device regulated under 21 CFR 866.3984. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2023
- Date Received
- March 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Covid-19 Antigen Test
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.