ClearanceBrief
510(k) K130765 ยท JIX Calibrator, Multi-Analyte Mixture

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

ApplicantElitechgroup, Bothell WA, US
DecisionSubstantially Equivalent, Apr 4, 2013
ReceivedMar 20, 2013
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K130765

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.