510(k) DEN240029
DEN240029 is an FDA 510(k) premarket notification submitted by Healgen for the device "Healgen Rapid Check COVID-19/Flu A&B Antigen Test". The FDA issued a decision of De Novo Granted on October 7, 2024. The device falls under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test), a Class II device regulated under 21 CFR 866.3987.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 7, 2024
- Date Received
- June 7, 2024
- Clearance Type
- Direct
- 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.