Becton Dickinson Advanced Diagnostics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Becton Dickinson Advanced Diagnostics” (first 1991, latest 1994), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Microbiology (2)
Most recent Becton Dickinson Advanced Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935667 | QTEST(R) STREP | GTY | 1994-04-21 | 146 |
| K931294 | IQ TUPTAKE ASSAY | KHQ | 1993-07-22 | 129 |
| K931295 | IQ TT4 ASSAY | CDX | 1993-07-20 | 127 |
| K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG | JHI | 1993-03-18 | 87 |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | JLW | 1992-12-28 | 76 |
| K923673 | PRECISE STREP A | GTZ | 1992-09-28 | 68 |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | JJE | 1992-09-15 | 82 |
| K914958 | RIATRAC PLUS | JJY | 1992-03-18 | 134 |
| K915197 | PRECISE TM HCG | JHI | 1991-12-17 | 28 |
| K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA | JHI | 1991-12-16 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Advanced Diagnostics.
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 Immunocytometry Systems (21 510(k)s)
- Becton Dickinson Vacutainer Systems (15 510(k)s)
- Becton Dickinson Diagnostic Instrument Systems (13 510(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 Advanced Diagnostics?
FDA lists 10 510(k) clearances under the applicant name “Becton Dickinson Advanced Diagnostics” (first 1991, latest 1994), across 8 product codes in 2 review panels. 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 Advanced Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Advanced Diagnostics is 84 days.
Which FDA product codes appear under Becton Dickinson Advanced Diagnostics?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 3); CDX (Radioimmunoassay, Total Thyroxine, 1); GTY (Antigens, All Groups, Streptococcus Spp., 1).
Next steps
- See all 10 Becton Dickinson Advanced Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JHI, Becton Dickinson Advanced Diagnostics'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.