Clungene RSV Antigen Rapid Test— 510(k) K253318
Substantially EquivalentHangzhou Clongene Biotech Co., Ltd.
FDA 510(k) clearance K253318 for Clungene RSV Antigen Rapid Test, Substantially Equivalent on 2026-01-30. Applicant: Hangzhou Clongene Biotech Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
- Product code
- Code GQG
- Device class
- Class 1
- Regulation
- 21 CFR 866.3480
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code GQG
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Data sourced from openFDA. This site is unofficial and independent of the FDA.