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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact