510(k) K253318
K253318 is an FDA 510(k) premarket notification submitted by Hangzhou Clongene Biotech Co., Ltd. for the device "Clungene RSV Antigen Rapid Test". The FDA issued a decision of Substantially Equivalent on January 30, 2026. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. Hangzhou Clongene Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2026
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device Class
- Class I
- Regulation Number
- 866.3480
- Review Panel
- MI
- Submission Type