The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Optilite Low Level Albumin Kit.
| Device ID | K153560 |
| 510k Number | K153560 |
| Device Name: | Optilite Low Level Albumin Kit |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, EDGBASTON Birmingham, GB B15 1qt |
| Contact | Jon Lauder |
| Correspondent | Jon Lauder THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, EDGBASTON Birmingham, 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 | 2015-12-14 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700018432 | K153560 | 000 |