510(k) K853867 ยท JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
| Applicant | Pantex, Div. Bio-Analysis, Inc., Santa Monica CA, US |
| Decision | Substantially Equivalent, Oct 4, 1985 |
| Received | Sep 17, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853867
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.