510(k) K983803 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 14, 1998 |
| Received | Oct 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983803
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.