The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Human Microalbumin Kit For Use On Spaplus.
| Device ID | K143118 |
| 510k Number | K143118 |
| Device Name: | Human Microalbumin Kit For Use On SPAPLUS |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, Birmingham, GB B15 1qt |
| Contact | Marianne Sender |
| Correspondent | Marianne Sender THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD, 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 | 2014-10-30 |
| Decision Date | 2015-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017923 | K143118 | 000 |