Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF— 510(k) K231348
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K231348 for Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF, Substantially Equivalent on 2023-06-05. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.