# Serono Baker Diagnostics System

- Location (FDA's records): Allentown, PA
- FDA decisions: 1 (1991–1991): 1 510(k) clearance
- Product codes: GKZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Biochem Immunosystems (U.S.), Inc.: 1 (https://510kreport.com/company/biochem-immunosystems-us)
- Serono Diagnostics, Inc.: 1 (https://510kreport.com/company/serono-diagnostics)

## Its most-cited devices
- K911626: System 9000, Interpretive Diff Cell Counter (1991), cited by 2

## Recent decisions
- K911626: System 9000, Interpretive Diff Cell Counter (Sep 13, 1991)

Source page: https://510kreport.com/company/serono-baker-diagnostics-system