510(k) K140686
- Device
- HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
- Applicant
- THE BINDING SITE GROUP LTD
- 510(k) number
- K140686
- Product code
- PDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-06
- Date received
- 2014-03-19
- Regulation
- 866.5510
- Classification name
- Immunoglobulin M 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
- SUZANNE HORNE
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 9614373
- 3012471076
Source Documents#
Other 510(k) Records For Product Code PDE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | The Binding Site Group , Ltd. | 2015-12-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary