Oxford Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Oxford Laboratories, Inc.” (first 1976, latest 1978), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DEX | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
Review panels
- Immunology (6)
- Clinical Chemistry (3)
Most recent Oxford Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780912 | ADJUSTABLE DISPENSOR | JQW | 1978-06-28 | 23 |
| K760148 | SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN | CZW | 1976-07-20 | 21 |
| K760147 | SERUM, IGM ANTI-HUMAN ACID | DFT | 1976-07-20 | 21 |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | CZP | 1976-07-20 | 21 |
| K760144 | SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID | DAD | 1976-07-20 | 21 |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | DEX | 1976-07-20 | 21 |
| K760079 | REAGENT, THYROXINE T4 (#210) | CDX | 1976-07-20 | 32 |
| K760078 | REAGENT, RIA TRIIODOTHYRONINE T3 (#200) | CDP | 1976-07-20 | 32 |
| K760145 | SERUM, IGG GOAT ANTI-HUMAN ACID | DEW | 1976-07-19 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Oxford Laboratories, 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.
- Oxford Medilog, Inc. (48 510(k)s)
- Oxford Performance Materials, Inc. (6 510(k)s)
- Oxford Instruments Medical Systems (5 510(k)s)
- Oxford Instruments, Plc. (5 510(k)s)
- Oxford Biosignals Limited (4 510(k)s)
- Oxford Instruments (2 510(k)s)
- Oxford Medical, Inc. (2 510(k)s)
- Oxford Metrics, Inc. (2 510(k)s)
- Oxford Brain Diagnostics, Ltd. (1 510(k)s)
- Oxford Instruments Medical , Ltd. (1 510(k)s)
- Oxford Immunotec, Ltd. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oxford Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Oxford Laboratories, Inc.” (first 1976, latest 1978), across 9 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 Oxford Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxford Laboratories, Inc. is 21 days.
Which FDA product codes appear under Oxford Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDX (Radioimmunoassay, Total Thyroxine, 1); CZP (Iga, Antigen, Antiserum, Control, 1).
Next steps
- See all 9 Oxford Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Oxford Laboratories, 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, 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.