FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
Minuteful - kidney test
K Number: K210069
·
Decision Jul 6, 2022
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
37
Applicant Total
4
Review Days
541
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Minuteful - kidney test
- K Number
- K210069
- 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
- January 11, 2021
- Decision Date
- July 6, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIR), ordered by most recent decision date.
Minuteful-kidney test
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TECO MICROALBUMIN 2-1 COMBO STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
FDA 510(k)
FDA Class 1
·Clinical Chemistry