510(k) K971689 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
| Applicant | Euro-Diagnostica AB, Ringoes NJ, US |
| Decision | Substantially Equivalent, Oct 29, 1997 |
| Received | May 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971689
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.