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FDA 510(k) Applications for Medical Device Product Code "QSE"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN200072
Fujirebio Diagnostics, Inc.
Lumipulse G ▀-Amyloid Ratio (1-42/1-40)
05/04/2022
K231348
Roche Diagnostics
Elecsys ▀-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
06/05/2023
K221842
Roche Diagnostics
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
12/07/2022
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