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Clungene RSV Antigen Rapid Test
FDA 510(k)Class I (US FDA 510(k))
510(k) K253318
Identifiers
- 510(k) Number
- K253318 FDA 510(k)
- FDA Product Code
- GQG FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3480 FDA 510(k)
- Regulation Number
- 866.3480 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clungene RSV Antigen Rapid Test by Hangzhou Clongene Biotech Co., Ltd. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253318 | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K253318 24 fields · synced Jun 19, 2026