FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
K Number: K252867
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
29
Applicant Total
3
Review Days
30
Basic Information
- Device Name
- VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
- K Number
- K252867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advin Biotech, Inc.
- Date Received
- September 9, 2025
- Decision Date
- October 9, 2025
- 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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