510(k) K231978
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 by
Vivachek Biotech (Hangzhou) Co., Ltd.
— Product Code NFW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2023
- Date Received
- July 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Cannabinoid, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type