FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
K Number: K220046
·
Decision Dec 13, 2022
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
1
Review Days
342
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Basic Information
- Device Name
- Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
- K Number
- K220046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Superbio Technology Co., Ltd.
- Date Received
- January 5, 2022
- Decision Date
- December 13, 2022
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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