FDA 510(k) Applications Submitted by Greg Mondics
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K231348 | 05/09/2023 | Elecsys ▀-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics |
| K221842 | 06/24/2022 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics |
| K142089 | 08/01/2014 | ACCU-CHEK AVIVA EXPERT SYSTEM | ROCHE DIAGNOSTICS CORPORATION |
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