Medical device manufacturer
THE BINDING SITE, INC.
THE BINDING SITE, INC. holds 125 FDA 510(k) clearances across 55 product codes. Median elapsed review time is 114 days. openFDA lists no recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 125
- Product codes
- 55
- Median review
- 114 days
- Recall records
- 0
How does FDA spell THE BINDING SITE, INC.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| THE BINDING SITE | device/registrationlisting | normalised |
| THE BINDING SITE, INC. | device/registrationlisting | normalised |
| The Binding Site | device/510k | normalised |
| The Binding Site, Ltd. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does THE BINDING SITE, INC. file in?
55 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 15 | 114 days | |
| DFH | Kappa, Antigen, Antiserum, Control | 8 | 70 days | |
| DEH | Lambda, Antigen, Antiserum, Control | 7 | 72 days | |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 6 | 231 days | |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 5 | 43 days | |
| MID | System, Test, Anticardiolipin Immunological | 5 | 107 days | |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 4 | 42 days | |
| CZJ | Igd, Antigen, Antiserum, Control | 4 | 105 days | |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 123 days | |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 4 | 345 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 86 days | |
| MST | Antibodies, Gliadin | 3 | 118 days | |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 3 | 144 days | |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | 153 days | |
| CZS | Retinol-Binding Protein, Antigen, Antiserum, Control | 2 | 35 days | |
| CZW | Complement C3, Antigen, Antiserum, Control | 2 | 100 days | |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 27 days | |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 198 days | |
| DDG | Transferrin, Antigen, Antiserum, Control | 2 | 62 days | |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 | 62 days | |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 2 | 75 days | |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 2 | 139 days | |
| JZO | System, Test, Thyroid Autoantibody | 2 | 74 days | |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | 57 days | |
| NDY | Test, Cystatin C | 2 | 114 days |
Showing the 25 they file in most, of 55.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has THE BINDING SITE, INC. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has THE BINDING SITE, INC. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | DFH | 265 | |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | OPX | 62 | |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | PCN | 128 | |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | CFN | 424 | |
| K100455 | SPAPLUS ANALYZER | DBI | 198 | |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | CFN | 273 | |
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | CZJ | 140 | |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | JZG | 180 | |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | CFN | 196 | |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | CFN | 175 |
Source: openFDA device/510k · retrieved
Where is THE BINDING SITE, INC. registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what THE BINDING SITE, INC. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.