The following data is part of a premarket notification filed by The Binding Site with the FDA for Cystatin C Kit For Use On The Spaplus Analyzer.
| Device ID | K072166 |
| 510k Number | K072166 |
| Device Name: | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER |
| Classification | Test, Cystatin C |
| Applicant | THE BINDING SITE 2425 WEST OLYMPIC BOULEVARD WEST TOWER SUITE 4000 Santa Monica, CA 90404 |
| Contact | Jay Geller |
| Correspondent | Jay Geller THE BINDING SITE 2425 WEST OLYMPIC BOULEVARD WEST TOWER SUITE 4000 Santa Monica, CA 90404 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2008-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017909 | K072166 | 000 |
| 05051700011624 | K072166 | 000 |