The following data is part of a premarket notification filed by The Binding Site Group, Ltd. with the FDA for Human Albumin Csf Kit.
| Device ID | K121045 |
| 510k Number | K121045 |
| Device Name: | HUMAN ALBUMIN CSF KIT |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD Edgbaston, GB B15 1qt |
| Contact | Jill Constantine |
| Correspondent | Jill Constantine THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD Edgbaston, GB B15 1qt |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2013-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700016193 | K121045 | 000 |