ClearanceBrief
510(k) K051435 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

ApplicantClinical Micro Sensors, Pasadena CA, US
DecisionSubstantially Equivalent, Jan 19, 2006
ReceivedJun 1, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K051435

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.