# Coulter Corp.

- Location (FDA's records): Miami, FL
- FDA decisions: 51 (1989–2000): 51 510(k) clearances
- Product codes: GKZ (23), JPK (5), GKL (3), CIG (2), KHS (2), GGL (1), CJE (1), JQB (1), JIY (1), CJY (1), CDQ (1), JGJ (1)
- Predicates its devices cite: 31 (16 its own); citations of its devices by later devices: 32 (16 its own)
- Recalls linked to its devices: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coulter Immunology: 6 (https://510kreport.com/company/coulter-immunology)
- Coulter Electronics, Inc.: 6 (https://510kreport.com/company/coulter-electronics)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Sysmex Corp.: 1 (https://510kreport.com/company/sysmex)

## Firms that cite its devices most
- Beckman Coulter, Inc.: 9 (https://510kreport.com/company/beckman-coulter)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Pointcare Technologies, Inc.: 2 (https://510kreport.com/company/pointcare-technologies)
- Abx Diagnostics: 1 (https://510kreport.com/company/abx-diagnostics)
- Gds Technology, LLC: 1 (https://510kreport.com/company/gds-technology)
- Ortho Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/ortho-diagnostic-systems)

## Its most-cited devices
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla (1999), cited by 5
- K962988: Coulter Gen-S System (1996), cited by 3
- K926124: Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 Mon (1993), cited by 3
- K896873: Coulter JT3 (1990), cited by 2
- K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col (1998), cited by 2
- K984216: Immuno-Trol Control Cells (1999), cited by 2

## Recent decisions
- K993356: Coulter Hematology Analyzers with Irf & MRV Analyses (Apr 20, 2000)
- K991070: Coulter Z2 Analyzer (May 11, 1999)
- K990327: Reticone System for Epics XL Flow Cytometry Systems (Apr 26, 1999)
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla (Apr 13, 1999)
- K990352: Coulter AC T Diff 2 Analyzer (Apr 1, 1999)
- K984216: Immuno-Trol Control Cells (Mar 16, 1999)
- K982167: Cyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1 (Nov 9, 1998)
- K982166: Cyto-Stat Trichrome CD45-Fitc/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1 (Nov 5, 1998)

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