The Binding Site, Ltd.: FDA filings under this applicant name
FDA lists 115 510(k) clearances under the applicant name “The Binding Site, Ltd.” (first 1988, latest 2024), across 51 product codes in 4 review panels. Median 510(k) review time under this name: 112 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 13 | 13 |
| 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 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 4 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 4 | 4 |
| CZJ | Igd, Antigen, Antiserum, Control | 3 | 3 |
Plus 41 more product codes.
Review panels
- Immunology (105)
- Clinical Chemistry (5)
- 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 |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | CFN | 2009-12-30 | 273 |
| 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 |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | MST | 2008-10-15 | 120 |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | NDY | 2008-06-06 | 114 |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | CFN | 2008-02-01 | 114 |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | DFH | 2007-11-30 | 242 |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | DFH | 2007-06-21 | 311 |
105 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):
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 Group , Ltd. (43 510(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, Ltd.?
FDA lists 115 510(k) clearances under the applicant name “The Binding Site, Ltd.” (first 1988, latest 2024), across 51 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 112 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), 13); DFH (Kappa, Antigen, Antiserum, Control, 8); DEH (Lambda, Antigen, Antiserum, Control, 7).
Next steps
- See all 115 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 (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.