510(k) K172613
- Device
- Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
- Applicant
- The Binding Site Group Ltd.
- 510(k) number
- K172613
- Product code
- PCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-15
- Date received
- 2017-08-31
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrea Thomas
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 3012471076
- 9614373
Source Documents#
Other 510(k) Records For Product Code PCN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | The Binding Site Group , Ltd. | 2016-10-04 |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | The Binding Site | 2013-12-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary