510(k) K100682 ยท JLX Radioimmunoassay, 17-Hydroxyprogesterone
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
| Applicant | Wallac OY, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Mar 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100682
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.