510(k) K041040 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
VARELISA MPO ANCA, MODEL 17648/17696
| Applicant | Sweden Diagnostics (Germany) GmbH, Freiburg, DE |
| Decision | Substantially Equivalent, Jun 16, 2004 |
| Received | Apr 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041040
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.