DeviceClearance

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF— 510(k) K221842

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K221842 for Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF, Substantially Equivalent on 2022-12-07. Applicant: Roche Diagnostics.

Clearance details

Applicant
Roche Diagnostics
Product code
Code QSE
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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