Becton Dickinson Immunocytometry Systems: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Becton Dickinson Immunocytometry Systems” (first 1989, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 244 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 21 | 21 |
Review panels
- Hematology (21)
Most recent Becton Dickinson Immunocytometry Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040725 | BD FACSCANTO SYSTEM | GKZ | 2004-09-10 | 172 |
| K040026 | BD FACS 7-COLOR SETUP BEADS | GKZ | 2004-09-10 | 247 |
| K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION | GKZ | 1998-05-22 | 78 |
| K974360 | MULTITEST CD3/CD8/CD45/CD4 | GKZ | 1998-03-11 | 112 |
| K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET | GKZ | 1998-02-17 | 155 |
| K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-12-01 | 244 |
| K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-25 | 244 |
| K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-21 | 297 |
| K965053 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-11-21 | 338 |
| K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | 1997-10-22 | 236 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Immunocytometry Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Becton, Dickinson & CO (196 510(k)s)
- Becton, Dickinson and Company (135 510(k)s)
- Becton Dickinson Infusion Therapy Systems, Inc. (36 510(k)s)
- Becton Dickinson Microbiology Systems (33 510(k)s)
- Becton Dickinson Vascular Access, Inc. (25 510(k)s)
- Becton Dickinson Vacutainer Systems (15 510(k)s)
- Becton Dickinson Diagnostic Instrument Systems (13 510(k)s)
- Becton Dickinson Advanced Diagnostics (10 510(k)s)
- Becton, Dickinson and Co. (6 510(k)s)
- Becton, Dickinson and Company (BD) (5 510(k)s)
- Becton Dickinson & Company (3 510(k)s)
- Becton Dickinson Consumer Products (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Becton Dickinson Immunocytometry Systems?
FDA lists 21 510(k) clearances under the applicant name “Becton Dickinson Immunocytometry Systems” (first 1989, latest 2004), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Becton Dickinson Immunocytometry Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Immunocytometry Systems is 244 days.
Which FDA product codes appear under Becton Dickinson Immunocytometry Systems?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 21).
Next steps
- See all 21 Becton Dickinson Immunocytometry Systems clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Becton Dickinson Immunocytometry Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.