510(k) K142985 ยท JIT Calibrator, Secondary
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 26, 2015 |
| Received | Oct 16, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142985
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.