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 Lambda Kit For Use On Spaplus.
| Device ID | K140686 |
| 510k Number | K140686 |
| Device Name: | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS |
| Classification | Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Contact | Suzanne Horne |
| Correspondent | Suzanne Horne THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Product Code | PDE |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-19 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700018289 | K140686 | 000 |
| 05051700018272 | K140686 | 000 |