The Binding Site, Ltd.: FDA filings under this applicant name
FDA lists 125 510(k) clearances under the applicant name “The Binding Site, Ltd.” (first 1988, latest 2024), across 55 product codes in 4 review panels. Median 510(k) review time under this name: 114 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 | 1 | 424 |
| 2013 | 1 | 128 |
| 2014 | 1 | 62 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 265 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Binding Site, Ltd. took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 218 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 15 | 15 |
| DFH | Kappa, Antigen, Antiserum, Control | 8 | 8 |
| DEH | Lambda, Antigen, Antiserum, Control | 7 | 7 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 6 | 6 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 5 | 5 |
| MID | System, Test, Anticardiolipin Immunological | 5 | 5 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 4 | 4 |
| CZJ | Igd, Antigen, Antiserum, Control | 4 | 4 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 4 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 4 | 4 |
Plus 45 more product codes.
Review panels
- Immunology (114)
- Clinical Chemistry (6)
- Hematology (4)
- Pathology (1)
Most recent The Binding Site, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | DFH | 2024-01-24 | 265 |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | OPX | 2014-03-18 | 62 |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | PCN | 2013-12-20 | 128 |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | CFN | 2012-02-27 | 424 |
| K100455 | SPAPLUS ANALYZER | DBI | 2010-09-03 | 198 |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | CFN | 2009-12-30 | 273 |
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | CZJ | 2009-12-28 | 140 |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | JZG | 2009-05-06 | 180 |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | CFN | 2009-02-10 | 196 |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | CFN | 2008-12-19 | 175 |
115 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Binding Site, Ltd..
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 The Binding Site, Ltd. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under The Binding Site, Ltd.?
FDA lists 125 510(k) clearances under the applicant name “The Binding Site, Ltd.” (first 1988, latest 2024), across 55 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 The Binding Site, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Binding Site, Ltd. is 114 days.
Which FDA product codes appear under The Binding Site, Ltd.?
The most frequent FDA product codes under this applicant name are CFN (Method, Nephelometric, Immunoglobulins (G, A, M), 15); DFH (Kappa, Antigen, Antiserum, Control, 8); DEH (Lambda, Antigen, Antiserum, Control, 7).
Next steps
- See all 125 The Binding Site, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CFN, The Binding Site, 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, 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.