510(k) K051297 ยท NEO System, Test, Osteocalcin
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | May 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051297
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.