K240351
- 510(k) number
- K240351
- Device name
- FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
- Applicant
- Assure Tech., LLC DE · US
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-03-06
- Date received
- 2024-02-05
- 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: K240351.pdf
Official FDA record: K240351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.