K240124
- 510(k) number
- K240124
- Device name
- BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2024-06-14
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240124.pdf
Official FDA record: K240124
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.