K240287 is an FDA 510(k) clearance for the LYHER® Oral fluid Multi-Drug Test Kit (Cube). This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by Hangzhou Laihe Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 18, 2025, 411 days after receiving the submission on February 1, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K240287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2024 |
| Decision Date | March 18, 2025 |
| Days to Decision | 411 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJC - Thin Layer Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |