510(k) K003668 ยท CGZ Electrode, Ion-Specific, Chloride
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
| Applicant | Wallac OY, Turku, FI |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Nov 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003668
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.