510(k) K943416 ยท CDX Radioimmunoassay, Total Thyroxine
DELFIA NEONATAL THYROXINE KIT
| Applicant | Wallac OY, Finland, FI |
| Decision | Substantially Equivalent, Mar 10, 1995 |
| Received | Jul 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943416
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.