510(k) K153361 ยท MRG System, Test, Vitamin D
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 15, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153361
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.