510(k) K160819
- Device
- Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- Applicant
- THE BINDING SITE GROUP LTD.
- 510(k) number
- K160819
- Product code
- OPX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-16
- Date received
- 2016-03-24
- Regulation
- 866.5510
- Classification name
- Immunoglobulin A Kappa Heavy & Light Chain Combined
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- JON LAUDER
- Address
- 8 Calthorpe Rd. Edgbaston GB B15 1QT B15 1QT
FDA Registration Numbers
- 3012471076
- 9614373
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700018494 | Optilite Hevylite® IgA Lambda Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700018487 | Optilite Hevylite® IgA Kappa Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
Other 510(k) Records For Product Code OPX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-11-06 |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | The Binding Site | 2014-03-18 |
Legacy Summary
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Decision Summary