K221871 is an FDA 510(k) clearance for the Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx. 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 30, 2022, 63 days after receiving the submission on June 28, 2022.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K221871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2022 |
| Decision Date | August 30, 2022 |
| Days to Decision | 63 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 |