510(k) K983805 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 26, 1999 |
| Received | Oct 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983805
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.