510(k) K151759
- Device
- Hevylite Human IgA Kappa Kit For Use On SPAPLUS, Hevylite Human IgA Lambda Kit For Use On SPAPLUS
- Applicant
- THE BINDING SITE GROUP LTD.
- 510(k) number
- K151759
- Product code
- OPX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-06
- Date received
- 2015-06-29
- 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
- STEPHANIE THOULESS
- Address
- 8 Caltrope 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 |
|---|---|---|---|
| 05051700017992 | Hevylite Human IgA Lambda SPA Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700017985 | Hevylite® Human IgA Kappa Kit for use on the SPAPL | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
Other 510(k) Records For Product Code OPX
Legacy Summary
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Decision Summary