FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ABL90 FLEX PLUS System
K Number: K252488
·
Decision May 1, 2026
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
5
Review Days
266
Basic Information
- Device Name
- ABL90 FLEX PLUS System
- K Number
- K252488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medicals Aps
- Date Received
- August 8, 2025
- Decision Date
- May 1, 2026
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Radiometer Medicals Aps
| K Number | Device Name | ||
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS System | May 1, 2026 | Substantially Equivalent |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Apr 10, 2026 | Substantially Equivalent |
| K241037 | ABL90 FLEX PLUS System | Jan 14, 2025 | Substantially Equivalent |
| K240998 | ABL90 FLEX PLUS System | Dec 13, 2024 | Substantially Equivalent |