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510(k) K242706

Device
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Applicant
Fujirebio Diagnostics,Inc.
510(k) number
K242706
Product code
SET
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-16
Date received
2024-09-09
Regulation
866.5840
Classification name
Immunoassay Blood Test For Amyloid Pathology Assessment
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stacey Dolan
Address
201 Great Valley Pkwy. Malvern PA US 19355 19355

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SET#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics2025-10-08