510(k) K060755 ยท CDD Radioassay, Vitamin B12
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 10, 2006 |
| Received | Mar 21, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060755
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.