510(k) K133512 ยท CDD Radioassay, Vitamin B12
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jan 2, 2014 |
| Received | Nov 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133512
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.