510(k) Report

Devices descending from K142898

3 later devices reach ABL800 FLEX with AQURE connectivity through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+2K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+3K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302