510(k) K083381 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
| Applicant | Euroimmun Us, Inc., Morristown NJ, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Nov 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083381
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.