K231904
- 510(k) number
- K231904
- Device name
- Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
- Applicant
- Co-Innovation Biotech Co., Ltd. CN
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2024-03-08
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231904.pdf
Official FDA record: K231904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.