The following data is part of a premarket notification filed by The Binding Site Group, Ltd. with the FDA for Human Alpha2-macroglobulin Kit For Use On Spaplus.
| Device ID | K140664 |
| 510k Number | K140664 |
| Device Name: | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS |
| Classification | Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD Edgbaston, GB B15 1qt |
| Contact | Jon Lauder |
| Correspondent | Jon Lauder THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD Edgbaston, GB B15 1qt |
| Product Code | DEB |
| CFR Regulation Number | 866.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017480 | K140664 | 000 |
| 05051700016469 | K140664 | 000 |