The Binding Site Group , Ltd.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “The Binding Site Group , Ltd.” (first 2010, latest 2025), across 18 product codes in 1 review panel. Median 510(k) review time under this name: 168 days. Since 2017 the median was 87 days, against 186 days for all cleared 510(k)s in the same product codes. 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 | 2 | 142 |
| 2013 | 10 | 430 |
| 2014 | 5 | 80 |
| 2015 | 6 | 148 |
| 2016 | 4 | 172 |
| 2017 | 1 | 265 |
| 2018 | 4 | 214 |
| 2019 | 6 | 28 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 178 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Binding Site Group , Ltd. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 14 | 14 |
| DFH | Kappa, Antigen, Antiserum, Control | 4 | 4 |
| DCF | Albumin, Antigen, Antiserum, Control | 3 | 3 |
| DAE | Complement C9, Antigen, Antiserum, Control | 2 | 2 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| OPX | Immunoglobulin A Kappa Heavy & Light Chain Combined | 2 | 2 |
| PCN | Immunoglobulin G Kappa Heavy And Light Chain Combined | 2 | 2 |
| PDE | Immunoglobulin M Kappa Heavy And Light Chain Combined | 2 | 2 |
Plus 8 more product codes.
Review panels
- Immunology (43)
Most recent The Binding Site Group , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | SGG | 2025-10-17 | 269 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | DFH | 2025-05-23 | 87 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | CFN | 2019-09-04 | 29 |
| K191985 | Optilite IgA Kit | CFN | 2019-08-19 | 25 |
| K191635 | Optilite IgM Kit | CFN | 2019-07-15 | 26 |
| K191465 | Human IgM Kit for use on SPAPlus | CFN | 2019-06-27 | 24 |
| K190686 | Optilite IgM CSF Kit | CFN | 2019-05-28 | 71 |
| K183151 | Optilite IgA CSF Kit | CFN | 2019-01-23 | 70 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | DCN | 2018-10-12 | 269 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | DFH | 2018-08-23 | 260 |
33 earlier clearances. See the full list in Caduvo.
Recalls
29 product recalls in 23 recall events; 2 initiated in the last five years. Most recent: 2026-04-16.
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.
- The Binding Site, Ltd. (115 510(k)s)
- The Binding Site (10 510(k)s)
- The Binding Site Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Binding Site Group , Ltd.?
FDA lists 43 510(k) clearances under the applicant name “The Binding Site Group , Ltd.” (first 2010, latest 2025), across 18 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 The Binding Site Group , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Binding Site Group , Ltd. is 168 days. Since 2017: 87 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under The Binding Site Group , Ltd.?
The most frequent FDA product codes under this applicant name are CFN (Method, Nephelometric, Immunoglobulins (G, A, M), 14); DFH (Kappa, Antigen, Antiserum, Control, 4); DCF (Albumin, Antigen, Antiserum, Control, 3).
Next steps
- See all 43 The Binding Site Group , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CFN, The Binding Site Group , 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.