K232604
- 510(k) number
- K232604
- Device name
- LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
- Applicant
- Hangzhou Laihe Biotech Co., Ltd. CN
- Product code
- LDJ — Enzyme Immunoassay, Cannabinoids
- Decision date
- 2024-01-10
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232604.pdf
Official FDA record: K232604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.