Oxoid U.S.A., Inc.: FDA filings under this applicant name
FDA lists 93 510(k) clearances under the applicant name “Oxoid U.S.A., Inc.” (first 1980, latest 1989), across 30 product codes in 4 review panels. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| JSK | Supplement, Culture Media | 30 | 30 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 11 | 11 |
| JSJ | Culture Media, Selective And Non-Differential | 10 | 10 |
| JSI | Culture Media, Selective And Differential | 7 | 7 |
| JSG | Culture Media, Non-Selective And Non-Differential | 5 | 5 |
| GMQ | Antigens, Nontreponemal, All | 3 | 3 |
| GNA | Antisera, All Types, Escherichia Coli | 2 | 2 |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 2 | 2 |
| KZJ | Device, Gas Generating | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
Plus 20 more product codes.
Review panels
- Microbiology (89)
- General Hospital (1)
- Immunology (1)
- Pathology (1)
Most recent Oxoid U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | JSI | 1989-06-09 | 81 |
| K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | GNA | 1989-02-03 | 133 |
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | KZI | 1988-10-25 | 19 |
| K874303 | STAPHYLASE TEST | LHT | 1987-11-06 | 17 |
| K872956 | SORBITOL MACCONKEY AGAR NO. 3 CM 813 | JSI | 1987-08-10 | 12 |
| K872135 | MCBRIDE MEDIUM CM 819 | JSJ | 1987-06-15 | 12 |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | JTL | 1987-06-10 | 93 |
| K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM | JSG | 1986-11-05 | 92 |
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | GTN | 1986-11-04 | 308 |
| K855235 | DIAGNOSTIC REAGENT PET-RPLA | JSP | 1986-11-04 | 308 |
83 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oxoid U.S.A., Inc..
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 , Ltd. (36 510(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 U.S.A., Inc.?
FDA lists 93 510(k) clearances under the applicant name “Oxoid U.S.A., Inc.” (first 1980, latest 1989), across 30 product codes in 4 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 Oxoid U.S.A., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxoid U.S.A., Inc. is 33 days.
Which FDA product codes appear under Oxoid U.S.A., Inc.?
The most frequent FDA product codes under this applicant name are JSK (Supplement, Culture Media, 30); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 11); JSJ (Culture Media, Selective And Non-Differential, 10).
Next steps
- See all 93 Oxoid U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSK, Oxoid U.S.A., Inc.'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.