K241100
- 510(k) number
- K241100
- Device name
- Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
- Applicant
- Co-Innovation Biotech Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-05-22
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241100.pdf
Official FDA record: K241100
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.