FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Glucose2
K Number: K252357
·
Decision Oct 24, 2025
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
2
Review Days
87
Basic Information
- Device Name
- Glucose2
- K Number
- K252357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland
- Date Received
- July 29, 2025
- Decision Date
- October 24, 2025
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
| K244042 | Calcium2 | Feb 10, 2025 | Substantially Equivalent |