The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Transferrin Kit For Use On The Spaplus.
| Device ID | K120236 |
| 510k Number | K120236 |
| Device Name: | TRANSFERRIN KIT FOR USE ON THE SPAPLUS |
| Classification | Transferrin, 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 | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-26 |
| Decision Date | 2013-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017640 | K120236 | 000 |
| 05051700016155 | K120236 | 000 |