The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Human Cystatin C Kit For Use On Modular P Analyser.
| Device ID | K080384 |
| 510k Number | K080384 |
| Device Name: | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER |
| Classification | Test, Cystatin C |
| Applicant | THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD 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 | 2008-02-13 |
| Decision Date | 2008-06-06 |