K231978 is an FDA 510(k) clearance for the BioSieve™ Marijuana Test Panel 50. This device is classified as a Test, Cannabinoid, Over The Counter (Class II - Special Controls, product code NFW).
Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 31, 2023, 59 days after receiving the submission on July 3, 2023.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K231978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | August 31, 2023 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NFW - Test, Cannabinoid, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |