FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
K Number: K260355
·
Decision Mar 9, 2026
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
29
Applicant Total
1
Review Days
34
Basic Information
- Device Name
- Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
- K Number
- K260355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WEBEST Biotech,, LLC
- Date Received
- February 3, 2026
- Decision Date
- March 9, 2026
- Product Code
- NFT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | FDA class 2 | Clinical Toxicology |
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