510(k) K092649 ยท NBC Test, Natriuretic Peptide
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 4, 2010 |
| Received | Aug 28, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092649
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.