Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
FDA 510(k) clearance K242706 · decided 2025-05-16
Clearance details
- K-number
- K242706
- Device name
- Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-09
- Decision date
- 2025-05-16
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- SET
- Device class
- 2
- Regulation number
- 866.5840
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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