K252118
- 510(k) number
- K252118
- Device name
- CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
- Applicant
- Hangzhou Clongene Biotech Co., Ltd. CN
- Product code
- NFT — Test, Amphetamine, Over The Counter
- Decision date
- 2025-08-27
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
510(k) Summary (official FDA PDF): K252118.pdf
Official FDA record: K252118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.