510(k) Report

Devices descending from K160402

2 later devices reach GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+2K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302