Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF— 510(k) K221842
Substantially EquivalentRoche 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. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code QSE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5840
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code QSE
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