# Serono-Baker Diagnostics, Inc.

- Location (FDA's records): Allentown, PA
- FDA decisions: 23 (1988–1992): 23 510(k) clearances
- Product codes: CHP (4), CDZ (2), CGR (2), DBF (2), JLS (2), KHQ (1), CFT (1), CEP (1), JJE (1), KLI (1), JLW (1), CEC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K924257: Testosterone Serozyme (TM) Enzyme Immunoassay (Nov 30, 1992)
- K915164: Sri Testosterone Enzyme Immunoassay (Mar 2, 1992)
- K914886: Sri (TM) Cortisol Enzyme Immunoassay (Mag Sol Phase) (Mar 2, 1992)
- K915602: Sri Digoxin Enzyme Immunoassay (Jan 17, 1992)
- K912937: SR1 Free T4 Enzyme Immunoassay (Nov 19, 1991)
- K914462: Sri Progesterone Enzyme Immunoassay (Mag Sold Phas) (Oct 23, 1991)
- K911912: SR1 T3 Uptake Enzyme Immunoassay (Mag Solid-Phase) (Sep 18, 1991)
- K911217: SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase) (Aug 16, 1991)

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