Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800

K060543 is the FDA 510(k) clearance record for ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800, a class II device, cleared for Clinical Micro Sensors, Inc. on 2006-03-28 under FDA product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection). FDA's definition for product code NUA reads: "The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected...". FDA records list 3 510(k) clearances for Clinical Micro Sensors, Inc., from 2006-01-19 to 2012-09-10. As of 2026-09-10, FDA records show no recalls naming K060543.