510(k) K123965 ยท CIG Diazo Colorimetry, Bilirubin
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 28, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123965
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.