The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys B-amyloid (1-42) Csf Ii, Elecsys Phospho-tau (181p) Csf.
| Device ID | K221842 |
| 510k Number | K221842 |
| Device Name: | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF |
| Classification | Alzheimer’s Disease Pathology Assessment Test |
| Applicant | Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 |
| Contact | Greg Mondics |
| Correspondent | Greg Mondics Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 |
| Product Code | QSE |
| CFR Regulation Number | 866.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-24 |
| Decision Date | 2022-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336208359 | K221842 | 000 |
| 07613336166321 | K221842 | 000 |
| 07613336208366 | K221842 | 000 |
| 07613336167663 | K221842 | 000 |