510(k) K170882 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
ABL90 FLEX, ABL90 FLEX PLUS
| Applicant | Radiometer Medical Aps, Broenshoej, DK |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Mar 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170882
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.