510(k) K081193 ยท CIG Diazo Colorimetry, Bilirubin
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 16, 2009 |
| Received | Apr 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081193
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.