The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Human Beta-2 Microglobulin Urine Kit For Use On The Spaplus.
| Device ID | K122066 |
| 510k Number | K122066 |
| Device Name: | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Contact | Jill Constantine |
| Correspondent | Jill Constantine THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON Birmingham, West Midlands, GB B15 1qt |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017688 | K122066 | 000 |
| 05051700016414 | K122066 | 000 |