510(k) K060452 ยท JLX Radioimmunoassay, 17-Hydroxyprogesterone
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
| Applicant | Neo-Genesis, Portland OR, US |
| Decision | Substantially Equivalent, Mar 13, 2007 |
| Received | Feb 21, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K060452
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.