# Coulter Immunology

- Location (FDA's records): Hialeah, FL
- FDA decisions: 16 (1988–1993): 16 510(k) clearances
- Product codes: GKZ (14), DEW (1), GGK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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
- Coulter Corp.: 6 (https://510kreport.com/company/coulter)

## Its most-cited devices
- K922744: Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1 (1993), cited by 3
- K922745: Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 (1993), cited by 3

## Recent decisions
- K922744: Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1 (Feb 5, 1993)
- K922745: Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 (Feb 5, 1993)
- K910473: Cyto-Stat (R)/Coulter Clone (R) T11-RD1/B4-Fitc (Oct 31, 1991)
- K911793: Coulterclone (Jul 9, 1991)
- K893852: Coulter Clone T4 Monoclonal Antibody (Mar 2, 1990)
- K893853: Coulter Clone T8 Monoclonal Antibody (Mar 2, 1990)
- K894179: Coulter Clone (R) MY4 Monoclonal Antibody (Feb 12, 1990)
- K895917: Cyto-Stat/Coulter Clone T4-RD1/T8-Fitc Mono Anti (Dec 29, 1989)

Source page: https://510kreport.com/company/coulter-immunology