510(k) K070458 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Dec 21, 2007 |
| Received | Feb 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070458
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.