K182701 is an FDA 510(k) clearance for the Wondfo T-Cup Multi-Drug Urine Test Cup. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K182701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | NFT — Test, Amphetamine, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |