ClearanceBrief
510(k) K200544 · CEM Electrode, Ion Specific, Potassium

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

ApplicantDiamond Diagnostics, Inc., Holliston MA, US
DecisionSubstantially Equivalent, Oct 1, 2020
ReceivedMar 3, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200544

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.