Burroughs Wellcome Co.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Burroughs Wellcome Co.” (first 1977, latest 1982), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 2 | 2 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DAC | Complement C3b Activator, Antigen, Antiserum, Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 1 | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (6)
- Immunology (5)
- Microbiology (4)
- Clinical Toxicology (2)
Most recent Burroughs Wellcome Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820069 | WELLCOGEN GROUP B | GTZ | 1982-02-18 | 37 |
| K813508 | SAC-CEL | KTS | 1981-12-29 | 14 |
| K810215 | DAC-CEL HCG | JHI | 1981-04-17 | 80 |
| K810214 | DAC-CEL DIAGNATAL | JHI | 1981-03-06 | 38 |
| K810213 | DAC-CEL TSH | JLW | 1981-02-10 | 14 |
| K810212 | DAC-CEL T3 UPTAKE | KHQ | 1981-02-10 | 14 |
| K791232 | DAC-CEL T3 | CDP | 1979-09-04 | 64 |
| K791231 | DAC-CEL T4 | CDX | 1979-09-04 | 64 |
| K781607 | STREP-TEX | GTZ | 1978-10-17 | 29 |
| K780874 | THYMUNE-T | DDC | 1978-06-14 | 15 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Burroughs Wellcome Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Burroughs Wellcome Co.?
FDA lists 17 510(k) clearances under the applicant name “Burroughs Wellcome Co.” (first 1977, latest 1982), across 13 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 Burroughs Wellcome Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burroughs Wellcome Co. is 29 days.
Which FDA product codes appear under Burroughs Wellcome Co.?
The most frequent FDA product codes under this applicant name are DDC (Thyroglobulin, Antigen, Antiserum, Control, 2); DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep., 2); GTZ (Antisera, All Groups, Streptococcus Spp., 2).
Next steps
- See all 17 Burroughs Wellcome Co. clearances with predicates and recalls
- Run predicate analysis for product code DDC, Burroughs Wellcome Co.'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.