510(k) K160757 ยท CDD Radioassay, Vitamin B12
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
| Applicant | Axis-Shield Diagnostics Limited, Dundee, Scotland, GB |
| Decision | Substantially Equivalent, Jul 26, 2016 |
| Received | Mar 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160757
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.