Submission Details
| 510(k) Number | K252118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 07, 2025 |
| Decision Date | August 27, 2025 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
Aug 2025
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K252118 is an FDA 510(k) clearance for the CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 27, 2025, 51 days after receiving the submission on July 7, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | NFT — Test, Amphetamine, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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