AXINON® LDL-p Test System— 510(k) K210801
Substantially EquivalentNumares AG
FDA 510(k) clearance K210801 for AXINON® LDL-p Test System, Substantially Equivalent on 2023-07-19. Applicant: Numares AG. Device class: 1.
Clearance details
- Applicant
- Numares AG
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Regensburg, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.