FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K Number: K182038
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
48
Applicant Total
1
Review Days
133
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Basic Information
- Device Name
- URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
- K Number
- K182038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Yd Diagnostics Corporation
- Date Received
- July 30, 2018
- Decision Date
- December 10, 2018
- Product Code
- JFY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | FDA class 2 | Clinical Chemistry |
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