510(k) K003664 ยท CGZ Electrode, Ion-Specific, Chloride
DELFIA NEONATAL IRT KIT, MODEL A005-110
| Applicant | Wallac OY, Turku, FI |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Nov 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003664
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.