510(k) K051489 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
| Applicant | Euroimmun Us, LLC, Boonton Twp NJ, US |
| Decision | Substantially Equivalent, Feb 16, 2006 |
| Received | Jun 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051489
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.