510(k) K924096 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
CMV ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 2, 1993 |
| Received | Aug 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2003 | Meridian Bioscience Inc Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. Terminated |
LFZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.