K191841 is an FDA 510(k) clearance for the Accurate Multi Panel Drug Urine Test Cup. This device is classified as a Test, Amphetamine, Over The Counter (Class II - Special Controls, product code NFT).
Submitted by Healstone Biotech, Inc. (Vancouver, CA). The FDA issued a Cleared decision on August 7, 2019, 29 days after receiving the submission on July 9, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K191841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2019 |
| Decision Date | August 07, 2019 |
| Days to Decision | 29 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 |