510(k) K072149 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Jan 15, 2008 |
| Received | Aug 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072149
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.