510(k) K082130 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
| Applicant | Euroimmun Us, Inc., Morristown NJ, US |
| Decision | Substantially Equivalent, Apr 7, 2009 |
| Received | Jul 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082130
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.