FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
Minuteful-kidney test
K Number: K222921
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
37
Applicant Total
4
Review Days
347
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Basic Information
- Device Name
- Minuteful-kidney test
- K Number
- K222921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healthy.Io, Ltd.
- Date Received
- September 26, 2022
- Decision Date
- September 8, 2023
- Product Code
- JIR
- 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 |
|---|---|---|---|
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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