Oxoid , Ltd.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Oxoid , Ltd.” (first 1997, latest 2007), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
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 | 31 | 31 |
| GNA | Antisera, All Types, Escherichia Coli | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 1 | 1 |
Review panels
- Microbiology (36)
Most recent Oxoid , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2007-03-14 | 47 |
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2006-03-17 | 42 |
| K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2004-09-14 | 35 |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | MYI | 2002-04-02 | 302 |
| K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M | LYR | 2001-12-10 | 122 |
| K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2001-04-24 | 60 |
| K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2001-04-24 | 60 |
| K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2000-05-22 | 61 |
| K000928 | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | JTN | 2000-05-15 | 54 |
| K993401 | DRYSPOT E.COLI 0157 KIT | GNA | 2000-02-28 | 143 |
26 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-12-23.
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.
- Oxoid U.S.A., Inc. (93 510(k)s)
- Oxoid Limited (Part of Thermo Fisher Scientific) (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oxoid , Ltd.?
FDA lists 36 510(k) clearances under the applicant name “Oxoid , Ltd.” (first 1997, latest 2007), across 6 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 Oxoid , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxoid , Ltd. is 60 days.
Which FDA product codes appear under Oxoid , Ltd.?
The most frequent FDA product codes under this applicant name are JTN (Susceptibility Test Discs, Antimicrobial, 31); GNA (Antisera, All Types, Escherichia Coli, 1); JWX (Kit, Screening, Staphylococcus Aureus, 1).
Next steps
- See all 36 Oxoid , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JTN, Oxoid , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.