510(k) K060700 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
| Applicant | Euroimmun Us, LLC, Boonton Twp NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2006 |
| Received | Mar 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060700
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.