510(k) K261280
K261280 is an FDA 510(k) premarket notification submitted by Vivachek Biotech (Hangzhou) Co., Ltd. for the device "BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Vivachek Biotech (Hangzhou) Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- April 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Amphetamine, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type