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510(k) DEN200072

Device
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Applicant
Fujirebio Diagnostics,Inc.
510(k) number
DEN200072
Product code
QSE
Decision
Unknown (DENG)
Decision date
2022-05-04
Date received
2020-11-20
Regulation
866.5840
Classification name
Alzheimer’S Disease Pathology Assessment Test
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QSE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics2023-06-05
K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics2022-12-07