510(k) K091860 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
AESKULISA MPO, MODEL 30-7303US
| Applicant | Aesku Diagnostics, Wendelsheim, Rheinland, DE |
| Decision | Substantially Equivalent, Feb 23, 2010 |
| Received | Jun 19, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091860
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.