FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
AXINON® LDL-p Test System
K Number: K210801
·
Decision Jul 19, 2023
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
1
Review Days
854
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Basic Information
- Device Name
- AXINON® LDL-p Test System
- K Number
- K210801
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Numares AG
- Date Received
- March 17, 2021
- Decision Date
- July 19, 2023
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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