510(k) K112443 ยท CDD Radioassay, Vitamin B12
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, Scotland, GB |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Aug 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112443
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.