The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite C1 Inactivator Kit.
| Device ID | K141100 |
| 510k Number | K141100 |
| Device Name: | OPTILITE C1 INACTIVATOR KIT |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Contact | Marianne Sender |
| Correspondent | Marianne Sender THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, 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 | 2014-04-29 |
| Decision Date | 2014-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017589 | K141100 | 000 |