FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
K Number: K173303
·
Decision Feb 23, 2018
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
223
Applicant Total
1
Review Days
128
Basic Information
- Device Name
- INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
- K Number
- K173303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alfa Scientific Designs, Inc
- Date Received
- October 18, 2017
- Decision Date
- February 23, 2018
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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