510(k) K071210 ยท LKO Anti-Rnp Antibody, Antigen And Control
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Dec 19, 2007 |
| Received | May 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071210
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.