510(k) K050960 ยท JLX Radioimmunoassay, 17-Hydroxyprogesterone
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
| Applicant | Wallac OY, Turku, FI |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | Apr 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050960
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.