Wellcome Diagnostics: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Wellcome Diagnostics” (first 1983, latest 1992), across 21 product codes in 3 review panels. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| GTJ | Antisera, All Groups, N. Meningitidis | 5 | 5 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 2 | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 | 1 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| GNB | Antisera, All Types, Shigella Spp. | 1 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
Plus 11 more product codes.
Review panels
- Microbiology (17)
- Hematology (7)
- Clinical Chemistry (4)
Most recent Wellcome Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915203 | D-DIMER WELLCOTEST (HA10) | DAP | 1992-01-31 | 74 |
| K910797 | STREPTEX ACID EXTRACTION KIT | GTZ | 1991-03-29 | 31 |
| K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 | GNB | 1990-01-11 | 127 |
| K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 | GRM | 1989-02-16 | 34 |
| K875311 | WELLCOZYME HSV WZO2 | GQN | 1988-08-03 | 218 |
| K861628 | WELLCOZYME ROTAVIRUS WZ01 | LIQ | 1987-01-21 | 267 |
| K864206 | REVEAL COLOUR STREP A ZL16 | GTZ | 1987-01-13 | 78 |
| K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 | LIQ | 1986-10-29 | 183 |
| K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT | GTJ | 1986-02-04 | 61 |
| K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | GTJ | 1986-02-04 | 61 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wellcome Diagnostics.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Wellcome Diagnostics (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Wellcome Diagnostics?
FDA lists 28 510(k) clearances under the applicant name “Wellcome Diagnostics” (first 1983, latest 1992), across 21 product codes in 3 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 Wellcome Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wellcome Diagnostics is 73 days.
Which FDA product codes appear under Wellcome Diagnostics?
The most frequent FDA product codes under this applicant name are GTJ (Antisera, All Groups, N. Meningitidis, 5); GTZ (Antisera, All Groups, Streptococcus Spp., 3); LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus, 2).
Next steps
- See all 28 Wellcome Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code GTJ, Wellcome Diagnostics'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.