The following data is part of a premarket notification filed by Shenzhen Bioeasy Biotechnology Co.,ltd. with the FDA for Bioeasy Marijuana Test Dip Card 40, Bioeasy Marijuana Test Dip Card 20, Bioeasy Marijuana Test Strip 40, Bioeasy Marijuana Test Strip 20.
| Device ID | K192515 |
| 510k Number | K192515 |
| Device Name: | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District Shenzhen, CN 518101 |
| Contact | Wenhau Yan |
| Correspondent | Joe Shia LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-13 |
| Decision Date | 2019-10-11 |
| Summary: | summary |