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510(k) K231348

Device
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
Applicant
Roche Diagnostics
510(k) number
K231348
Product code
QSE
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-05
Date received
2023-05-09
Regulation
866.5840
Classification name
Alzheimer?S Disease Pathology Assessment Test
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Greg Mondics
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics2022-12-07
DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc.2022-05-04