510(k) K140105
- Device
- HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
- Applicant
- THE BINDING SITE
- 510(k) number
- K140105
- Product code
- OPX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-18
- Date received
- 2014-01-15
- 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
Applicant Contact#
- Contact
- Paul Kenny
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 3012471076
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OPX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | The Binding Site Group , Ltd. | 2016-06-16 |
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary