# Serono Diagnostics, Inc.

- Location (FDA's records): Norwell, MA
- FDA decisions: 25 (1984–1996): 25 510(k) clearances
- Product codes: CEP (3), JHI (2), CGJ (2), JLW (2), CFT (2), LJP (1), CHP (1), JKD (1), KHQ (1), GQH (1), KLI (1), LKI (1)
- Predicates its devices cite: 2 (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 whose devices it cites most
- Serono Baker Diagnostics System: 1 (https://510kreport.com/company/serono-baker-diagnostics-system)
- Baker Instructions Corp.: 1 (https://510kreport.com/company/baker-instructions)

## Firms that cite its devices most
- Abx Diagnostics: 1 (https://510kreport.com/company/abx-diagnostics)
- Genosis, Ltd.: 1 (https://510kreport.com/company/genosis)

## Its most-cited devices
- K862813: FSH Maiaclone Immunoradiometric Assay Kit (1986), cited by 1
- K953598: Series 9100 Plus Automated Differential Hematology Analyzers (1996), cited by 1

## Recent decisions
- K953598: Series 9100 Plus Automated Differential Hematology Analyzers (Mar 11, 1996)
- K942051: SR1 Dhea-S Enzyme Immunoassay (Jul 13, 1994)
- K883085: T3 Uptake Serozyme Enzyme Immuno KT/Mag Solid Phas (Sep 9, 1988)
- K882340: LH Serozyme Immunoenzymetric Assay Kit,Mag Sol Pha (Aug 8, 1988)
- K880388: T3 Serozyme Enzymeimmunoassay Kit, Mag Solid Phase (Mar 3, 1988)
- K874866: T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid Phase (Feb 11, 1988)
- K873431: Progesterone Maia Radioimmuno Assay Kit Mag SLD PH (Oct 20, 1987)
- K873186: LH Maiaclone Immunoradio. Assay Kit, Mag Solid Pha (Sep 29, 1987)

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