The following data is part of a premarket notification filed by The Binding Site Group, Ltd. with the FDA for Human C1 Inactivator Kit For Use On Spaplus.
| Device ID | K122304 |
| 510k Number | K122304 |
| Device Name: | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD WEST MIDLANDS Edgbaston, GB B15 1qt |
| Contact | Jill Constantine |
| Correspondent | Jill Constantine THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD WEST MIDLANDS Edgbaston, GB B15 1qt |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2013-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700016674 | K122304 | 000 |