# Alere Technologies AS

- Location (FDA's records): Oslo, NO
- FDA decisions: 3 (2015–2018): 3 510(k) clearances
- Product codes: PDJ (2), LCP (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Axis-Shield Poc AS: 2 (https://510kreport.com/company/axis-shield-poc)
- Roche Diagnostics Operations: 1 (https://510kreport.com/company/roche-diagnostics-operations)

## Firms that cite its devices most
- Jana Care, Inc.: 1 (https://510kreport.com/company/jana-care)
- Skyla Corporation H.S.P.B: 1 (https://510kreport.com/company/skyla-hspb)
- Ekf-Diagnostic GmbH: 1 (https://510kreport.com/company/ekf-diagnostic)
- Abbott Diagnostics Technologies AS: 1 (https://510kreport.com/company/abbott-diagnostics-technologies)
- Abbott Rapid Diagnostics: 1 (https://510kreport.com/company/abbott-rapid-diagnostics)

## Its most-cited devices
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (2015), cited by 5
- K180296: Afinion HbA1c Dx (2018), cited by 1

## Recent decisions
- K182988: Afinion HbA1c Dx on Afinion 2 (Nov 29, 2018)
- K180296: Afinion HbA1c Dx (May 7, 2018)
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (Sep 25, 2015)

Source page: https://510kreport.com/company/alere-technologies