510(k) K031563 ยท DAK Complement C1q, Antigen, Antiserum, Control
BINDAZYME CLQ CIC EIA KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Sep 10, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2010 | Inova Diagnostics Incorporated Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021 Terminated |
DAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.