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BioSieve™ Marijuana Test Panel 50 +5 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K231978
Identifiers
- 510(k) Number
- K231978 FDA 510(k)
- FDA Product Code
- NFW FDA 510(k)
- Models / Variants
- BioSieve™ Marijuana Test Panel 50 FDA 510(k)BioSieve™ Marijuana Test Strip 50 FDA 510(k)BioSieve™ Dx Marijuana Test Strip 20 FDA 510(k)BioSieve™ Dx Marijuana Test Strip 50 FDA 510(k)BioSieve™ Dx Marijuana Test Panel 20 FDA 510(k)BioSieve™ Dx Marijuana Test Panel 50 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BioSieve™ Marijuana Test Panel 50 +5 more models by VivaChek Biotech (Hangzhou) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 6 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 | K231978 | Class II | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K231978 24 fields · synced Jun 18, 2026