510(k) K062467 ยท CDD Radioassay, Vitamin B12
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Aug 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062467
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.