510(k) K040174 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 14, 2004 |
| Received | Jan 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040174
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.