510(k) K013283 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
| Applicant | Immuno Concepts, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Nov 14, 2001 |
| Received | Oct 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013283
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.