K021887 is an FDA 510(k) clearance for the CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Lin-Zhi International, Inc. (San Jose, US). The FDA issued a Cleared decision on August 15, 2002, 69 days after receiving the submission on June 7, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K021887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2002 |
| Decision Date | August 15, 2002 |
| Days to Decision | 69 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 |