K232597
- 510(k) number
- K232597
- Device name
- LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
- Applicant
- Hangzhou Laihe Biotech Co., Ltd. CN
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2024-01-09
- 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: K232597.pdf
Official FDA record: K232597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.