Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio— 510(k) K242706
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K242706 for Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, Substantially Equivalent on 2025-05-16. Applicant: Fujirebio Diagnostics,Inc..
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code SET
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.