The following data is part of a premarket notification filed by The Binding Site Group Ltd with the FDA for Human Ch50 Reagent Pack For Use On The Spaplus, Human Ch50 Calibrator Set For Use On The Spaplus, Human Ch50 Controls Fo.
| Device ID | K113349 |
| 510k Number | K113349 |
| Device Name: | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO |
| Classification | Complement C9, 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 | DAE |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700015615 | K113349 | 000 |
| 05051700015608 | K113349 | 000 |
| 05051700015592 | K113349 | 000 |