Submission Details
| 510(k) Number | K252550 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2025 |
| Decision Date | November 18, 2025 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
Nov 2025
Decision
97d
Days
Class 2
Risk
About This 510(k) Submission
K252550 is an FDA 510(k) clearance for the SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 18, 2025, 97 days after receiving the submission on August 13, 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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