510(k) K813493 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ENZYGNOST TM RUBELLA IGM
| Applicant | Calbiochem-Behring Corp., Walker MI, US |
| Decision | Substantially Equivalent, Mar 4, 1982 |
| Received | Dec 14, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813493
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.