K192515 is an FDA 510(k) clearance for the BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 11, 2019, 28 days after receiving the submission on September 13, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K192515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2019 |
| Decision Date | October 11, 2019 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ - Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |