# The Binding Site, Ltd.

- Location (FDA's records): Santa Monica, CA
- FDA decisions: 125 (1988–2024): 125 510(k) clearances
- Names in FDA's records: The Binding Site, Ltd. (115); The Binding Site (10)
- Product codes: CFN (15), DFH (8), DEH (7), JZG (6), MID (5), LLL (5), MSV (4), CZJ (4), MOB (4), CFQ (4), DCK (3), MST (3)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 26 (1 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- The Binding Site Group, Ltd.: 8 (https://510kreport.com/company/binding-site-group)
- Siemens Healthcare Diagnostics Products GmbH: 4 (https://510kreport.com/company/siemens-healthcare-diagnostics-products)
- Immuno Concepts, Inc.: 3 (https://510kreport.com/company/immuno-concepts)
- Diazyme Laboratories: 3 (https://510kreport.com/company/diazyme-laboratories)
- Rhigene, Inc.: 2 (https://510kreport.com/company/rhigene)
- Sebia: 2 (https://510kreport.com/company/sebia)
- Biomedical Diagnostics S.A.: 2 (https://510kreport.com/company/biomedical-diagnostics)
- Inova Diagnostics, Inc.: 1 (https://510kreport.com/company/inova-diagnostics)

## Its most-cited devices
- K031016: Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II (2003), cited by 6
- K040009: Freelite Human Kappa and Lambda Kits (2004), cited by 3
- K082129: Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer (2009), cited by 2
- K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit (1998), cited by 2
- K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus (2012), cited by 2
- K981030: Bindazyme Anti-Mpo Enzyme Immunoassay Kit (1998), cited by 2

## Recent decisions
- K231290: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (Jan 24, 2024)
- K140105: Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii (Mar 18, 2014)
- K132555: Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit (Dec 20, 2013)
- K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus (Feb 27, 2012)
- K100455: Spaplus Analyzer (Sep 3, 2010)
- K090920: Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P) (Dec 30, 2009)
- K092450: Human Igd Kit for Use on Spaplus (Dec 28, 2009)
- K083289: Human Beta-2 Microglobulin Kit (May 6, 2009)

Source page: https://510kreport.com/company/binding-site