# Becton Dickinson Immunocytometry Systems

- Location (FDA's records): San Jose, CA
- FDA decisions: 21 (1989–2004): 21 510(k) clearances
- Product codes: GKZ (21)
- Predicates its devices cite: 27 (18 its own); citations of its devices by later devices: 42 (18 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 6 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Becton Dickinson Monoclonal Center: 2 (https://510kreport.com/company/becton-dickinson-monoclonal-center)
- Bd Biosciences: 1 (https://510kreport.com/company/bd-biosciences)

## Firms that cite its devices most
- Bd Biosciences: 6 (https://510kreport.com/company/bd-biosciences)
- Cylex, Inc.: 4 (https://510kreport.com/company/cylex)
- Becton, Dickinson & CO: 4 (https://510kreport.com/company/becton-dickinson)
- Beckman Coulter, Inc.: 3 (https://510kreport.com/company/beckman-coulter)
- Dakocytomation California, Inc.: 2 (https://510kreport.com/company/dakocytomation-california)
- Guava Technologies, Inc.: 2 (https://510kreport.com/company/guava-technologies)
- Reametrix, Inc.: 1 (https://510kreport.com/company/reametrix)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)

## Its most-cited devices
- K974360: Multitest CD3/CD8/CD45/CD4 (1998), cited by 7
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set (1998), cited by 5
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes (1997), cited by 4
- K933486: Fascount Systme (1994), cited by 4
- K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes (1997), cited by 3
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution (1998), cited by 3

## Recent decisions
- K040725: BD Facscanto System (Sep 10, 2004)
- K040026: BD Facs 7-Color Setup Beads (Sep 10, 2004)
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution (May 22, 1998)
- K974360: Multitest CD3/CD8/CD45/CD4 (Mar 11, 1998)
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set (Feb 17, 1998)
- K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes (Dec 1, 1997)
- K971110: Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count Tubes (Nov 25, 1997)
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes (Nov 21, 1997)

Source page: https://510kreport.com/company/becton-dickinson-immunocytometry-systems