510(k) K973897 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
DHEA-S
| Applicant | Kmi Diagnostics, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 13, 1997 |
| Received | Oct 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973897
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.