K192301 is an FDA 510(k) clearance for the BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip. This device is classified as a Test, Cannabinoid, Over The Counter (Class II - Special Controls, product code NFW).
Submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 20, 2019, 28 days after receiving the submission on August 23, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K192301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2019 |
| Decision Date | September 20, 2019 |
| Days to Decision | 28 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 |