510(k) Report

Devices descending from K943754

2 later devices reach Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN…Edan Instruments, Inc.20160—
+1K050983Irma Trupoint Creatinine Control KitInternational Technidyne Corporation20050—