510(k) K153375 ยท MRG System, Test, Vitamin D
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 12, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.