Submission Details
| 510(k) Number | K182701 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2018 |
| Decision Date | December 03, 2018 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Wondfo T-Cup Multi-Drug Urine Test Cup
Dec 2018
Decision
67d
Days
Class 2
Risk
About This 510(k) Submission
K182701 is an FDA 510(k) clearance for the Wondfo T-Cup Multi-Drug Urine Test Cup, 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 December 3, 2018, 67 days after receiving the submission on September 27, 2018. 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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