K241869
- 510(k) number
- K241869
- Device name
- BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-10-04
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241869.pdf
Official FDA record: K241869
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.