510(k) K003174 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
ELECSYS DHEA-S
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 17, 2001 |
| Received | Oct 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003174
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.