510(k) K053653 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
FIDIS CONNECTIVE 10, MODEL MX006
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Mar 13, 2006 |
| Received | Dec 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053653
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.