# Fujirebio Dianostics, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 1 (2019–2019): 1 510(k) clearance
- Product codes: NIG (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 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
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)

## Firms that cite its devices most
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)

## Its most-cited devices
- K191973: Lumpipulse G CA19-9-N (2019), cited by 1

## Recent decisions
- K191973: Lumpipulse G CA19-9-N (Oct 22, 2019)

Source page: https://510kreport.com/company/fujirebio-dianostics