BioSieve Marijuana Test Panel 50 +5 more— 510(k) K231978
Substantially EquivalentVivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K231978 for BioSieve Marijuana Test Panel 50 +5 more, Substantially Equivalent on 2023-08-31. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Product code NFW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.