FDA 510(k) Applications Submitted by Monica Vallestad
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K180296 | 02/02/2018 | Afinion HbA1c Dx | Alere Technologies AS |
| K171650 | 06/05/2017 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics |
| K182988 | 10/29/2018 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS |
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