510(k) K942051 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
SR1 DHEA-S ENZYME IMMUNOASSAY
| Applicant | Serono Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Jul 13, 1994 |
| Received | Apr 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942051
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.