510(k) K121994 ยท CDD Radioassay, Vitamin B12
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 30, 2012 |
| Received | Jul 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121994
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.