510(k) K233541 ยท CDD Radioassay, Vitamin B12
ARCHITECT Active-B12 (Holotranscobalamin)
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jul 31, 2024 |
| Received | Nov 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233541
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.