FDA applicant
Becton Dickinson Immunocytometry Systems
FDA records 21 decisions for Becton Dickinson Immunocytometry Systems (San Jose, CA) from 1989 to 2004: 21 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Its devices cite 27 predicates, 18 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Becton Dickinson Immunocytometry Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Becton Dickinson Immunocytometry Systems since 2007.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Becton Dickinson Immunocytometry Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Becton”
FDA records each applicant name separately; these may or may not be the same firm.