K233417
- 510(k) number
- K233417
- Device name
- AllTest Fentanyl Urine Test Cassette
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2023-10-26
- Date received
- 2023-10-10
- 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: K233417.pdf
Official FDA record: K233417
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.