The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Hevylite Human Igm Kappa And Hevylite Igm Lambda Kit.
| Device ID | K113823 |
| 510k Number | K113823 |
| Device Name: | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Contact | Jill Constantine |
| Correspondent | Jill Constantine THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Product Code | CFN |
| Subsequent Product Code | PDE |
| Subsequent Product Code | |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2013-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017008 | K113823 | 000 |
| 05051700016995 | K113823 | 000 |