K221842

Substantially Equivalent

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

Applicant: Roche Diagnostics
Product code: QSE
Advisory panel: Immunology
Date received: 2022-06-24
Decision date: 2022-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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