510(k) K984180 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jul 20, 1999 |
| Received | Nov 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2003 | Zeus Scientific Inc Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigm Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.