K240287
- 510(k) number
- K240287
- Device name
- LYHER® Oral fluid Multi-Drug Test Kit (Cube)
- Applicant
- Hangzhou Laihe Biotech Co., Ltd. CN
- Product code
- DJC — Thin Layer Chromatography, Methamphetamine
- Decision date
- 2025-03-18
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240287.pdf
Official FDA record: K240287
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.