← Back to catalogue
BioSieve™ Fentanyl FIA Home Test Kit +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K241869
Identifiers
- 510(k) Number
- K241869 FDA 510(k)
- FDA Product Code
- NGL FDA 510(k)
- Models / Variants
- BioSieve™ Fentanyl FIA Home Test Kit FDA 510(k)BioSieve™ Fentanyl FIA Pro Test Kit FDA 510(k)BioSieve™ Toxismart Reader FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BioSieve™ Fentanyl FIA Home Test Kit +2 more models by VivaChek Biotech (Hangzhou) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241869 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K241869 24 fields · synced Jun 18, 2026