Becton Dickinson Microbiology Systems: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Becton Dickinson Microbiology Systems” (first 1992, latest 1999), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 67 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 12 | 12 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 4 | 4 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 3 | 3 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 3 | 3 |
| MDB | System, Blood Culturing | 3 | 3 |
| JSS | Kit, Identification, Enterobacteriaceae | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 2 |
| JSP | Kit, Anaerobic Identification | 1 | 1 |
| JST | Kit, Fastidious Organisms | 1 | 1 |
| LQL | Gram Positive Identification Panel | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (33)
Most recent Becton Dickinson Microbiology Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | JTN | 1999-12-01 | 41 |
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY | LSL | 1999-11-04 | 309 |
| K981517 | CEFDINIR, 5 UG, SENSI-DISC | JTN | 1998-06-09 | 42 |
| K980683 | TROVAFLOXACIN 10G, SENSI-DISC | JTN | 1998-05-01 | 67 |
| K974578 | GREPAFLOXACIN, 5 MG, SENSI-DISC | JTN | 1998-02-23 | 77 |
| K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | MDB | 1998-01-28 | 365 |
| K970512 | BACTEC MYCO/F LYTIC CULTURE VIALS | MDB | 1998-01-08 | 331 |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | MDB | 1997-08-08 | 53 |
| K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | JTN | 1997-07-28 | 54 |
| K970385 | SPARFLOZACIN, 5 MCG, SENSI-DISC | JTN | 1997-03-10 | 35 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Becton Dickinson Microbiology 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 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 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 Microbiology Systems?
FDA lists 33 510(k) clearances under the applicant name “Becton Dickinson Microbiology Systems” (first 1992, latest 1999), across 11 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 Becton Dickinson Microbiology Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Becton Dickinson Microbiology Systems is 67 days.
Which FDA product codes appear under Becton Dickinson Microbiology Systems?
The most frequent FDA product codes under this applicant name are JTN (Susceptibility Test Discs, Antimicrobial, 12); JWY (Manual Antimicrobial Susceptibility Test Systems, 4); JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, 3).
Next steps
- See all 33 Becton Dickinson Microbiology Systems clearances with predicates and recalls
- Run predicate analysis for product code JTN, Becton Dickinson Microbiology 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.