510(k) K102607 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
| Applicant | Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Sep 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102607
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.