510(k) K984315 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 17, 1998 |
| Received | Dec 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984315
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.