BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader
FDA 510(k) clearance K241869 · decided 2024-10-04
Clearance details
- K-number
- K241869
- Device name
- BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-27
- Decision date
- 2024-10-04
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.