510(k) K953586 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
VARELISA PR3-ANCA
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, Jan 26, 1996 |
| Received | Aug 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953586
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.