# Biogen

- Location (FDA's records): Cambridge, MA
- FDA decisions: 2 (2003–2004): 2 510(k) clearances
- Product codes: KZH (1), FMF (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (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
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Owen Mumford USA, Inc.: 1 (https://510kreport.com/company/owen-mumford-usa)
- Sterling Drug, Inc.: 1 (https://510kreport.com/company/sterling-drug)

## Firms that cite its devices most
- Pharma-Pen, Inc.: 1 (https://510kreport.com/company/pharma-pen)

## Its most-cited devices
- K032425: Invisiject Resusable Auto-Injector (2003), cited by 2

## Recent decisions
- K042314: Syringe Grip for the Avonex Pre-Filled Syringe (Nov 22, 2004)
- K032425: Invisiject Resusable Auto-Injector (Nov 5, 2003)

Source page: https://510kreport.com/company/biogen