The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Human Kappa And Lambda Free Kitfor Use On The Spa Plus Analyser.
| Device ID | K120056 |
| 510k Number | K120056 |
| Device Name: | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER |
| Classification | Kappa, Antigen, Antiserum, Control |
| 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 | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2013-04-01 |
| Summary: | summary |