510(k) K063543 ยท CIG Diazo Colorimetry, Bilirubin
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Nov 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063543
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.