510(k) K983418 ยท DHR System, Test, Rheumatoid Factor
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983418
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.