# Axis-Shield Poc AS

- Location (FDA's records): Oslo, NO
- FDA decisions: 4 (2005–2014): 4 510(k) clearances
- Product codes: LCP (2), JFY (1), CHH (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bayer Corp.: 1 (https://510kreport.com/company/bayer)
- Heraeus Kulzer, Inc.: 1 (https://510kreport.com/company/heraeus-kulzer)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)
- Cliniqa Corporation: 1 (https://510kreport.com/company/cliniqa)

## Firms that cite its devices most
- Abbott Rapid Diagnostics: 3 (https://510kreport.com/company/abbott-rapid-diagnostics)
- Alere Technologies AS: 2 (https://510kreport.com/company/alere-technologies)
- Sd Biosensor: 1 (https://510kreport.com/company/sd-biosensor)
- Nova Biomedical Corp.: 1 (https://510kreport.com/company/nova-biomedical)

## Its most-cited devices
- K110056: Afinion Analyzer (2011), cited by 3
- K050574: Afinion Hbalc (2005), cited by 3
- K072409: Afinion Acr and Acr Control (2008), cited by 2

## Recent decisions
- K132031: Afinion Lipid Panel and Afinion Lipid Panel Control (Mar 21, 2014)
- K110056: Afinion Analyzer (Feb 15, 2011)
- K072409: Afinion Acr and Acr Control (Feb 12, 2008)
- K050574: Afinion Hbalc (Jul 22, 2005)

Source page: https://510kreport.com/company/axis-shield-poc