510(k) K984034 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Nov 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984034
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.