FDA.reportPublic FDA data

Device Listing 2016342030

Listing Summary#

Listing key
2016342030
Premarket submission
K231348
Device
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
Applicant
Roche Diagnostics
Product code
QSE
Decision date
2023-06-05