510(k) K914028 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELLA IGM ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 22, 1992 |
| Received | Sep 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914028
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.