510(k) K914420 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ELISA RUBELLA IGM
| Applicant | Sclavo, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Dec 27, 1991 |
| Received | Oct 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914420
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.