Abbott Diagnostics Technologies AS
Medical device manufacturer in Oslo, Norw.
1510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | 09/27/2023SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2736-2024 Class II | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to… | 06/17/2024Open, Classified |
| Z-2192-2020 Class II | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556…The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the… | 03/23/2020Open, Classified |