510(k) K100917 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Nov 3, 2010 |
| Received | Apr 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100917
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.