510(k) K161854
- Device
- Hevylite Human IgG Kappa Kit For Use On The SPAPLUS, Hevylite Human IgG Lambda Kit For Use On The SPAPLUS
- Applicant
- THE BINDING SITE GROUP LTD
- 510(k) number
- K161854
- Product code
- PCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-10-04
- Date received
- 2016-07-06
- Regulation
- 866.5510
- Classification name
- Immunoglobulin G Kappa Heavy And 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
- ANDREA THOMAS
- 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 |
|---|---|---|---|
| 05051700019385 | Hevylite Human IgG Lambda Kit for use on the SPAPL | THE BINDING SITE GROUP LIMITED | 2017-07-25 |
| 05051700019378 | Hevylite Human IgG Kappa Kit for use on the SPAPLU | THE BINDING SITE GROUP LIMITED | 2017-07-25 |
Other 510(k) Records For Product Code PCN
Legacy Summary
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FDA Review
Decision Summary