510(k) K080384 ยท NDY Test, Cystatin C
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Jun 6, 2008 |
| Received | Feb 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080384
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.