510(k) K980646 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, May 6, 1998 |
| Received | Feb 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980646
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.