510(k) K142362 ยท MRG System, Test, Vitamin D
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142362
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.