FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Calcium2
K Number: K244042
·
Decision Feb 10, 2025
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
2
Review Days
42
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Basic Information
- Device Name
- Calcium2
- K Number
- K244042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland
- Date Received
- December 30, 2024
- Decision Date
- February 10, 2025
- Product Code
- CJY
- 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 |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Abbott Ireland
| K Number | Device Name | ||
|---|---|---|---|
| K252357 | Glucose2 | Oct 24, 2025 | Substantially Equivalent |