510(k) K062183 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Nov 21, 2006 |
| Received | Jul 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062183
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.