Bd Biosciences: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bd Biosciences” (first 2000, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 96 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 | 1 | 269 |
| 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 | 9 | 9 |
| OYE | Flow Cytometric Reagents And Accessories. | 1 | 1 |
Review panels
- Hematology (10)
Most recent Bd Biosciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | OYE | 2015-02-27 | 269 |
| K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | GKZ | 2009-07-31 | 116 |
| K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | GKZ | 2008-08-14 | 106 |
| K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 | GKZ | 2007-06-06 | 43 |
| K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 | GKZ | 2007-06-06 | 43 |
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 | GKZ | 2006-09-14 | 52 |
| K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 | GKZ | 2006-06-06 | 113 |
| K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE | GKZ | 2004-09-17 | 144 |
| K000611 | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER | GKZ | 2000-05-18 | 85 |
| K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE | GKZ | 2000-05-05 | 45 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2007-12-21.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bd Biosciences?
FDA lists 10 510(k) clearances under the applicant name “Bd Biosciences” (first 2000, latest 2015), across 2 product codes 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 Bd Biosciences?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bd Biosciences is 96 days.
Which FDA product codes appear under Bd Biosciences?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 9); OYE (Flow Cytometric Reagents And Accessories., 1).
Next steps
- See all 10 Bd Biosciences clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Bd Biosciences'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.