510(k) Report

Devices descending from K112995

11 later devices reach Gem Premier 4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO20162—
+1K133407Gem Premier 4000Instrumentation Laboratory CO201410—
+2K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+2K183549GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+2K183546GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+2K173403GEM Premier 5000Instrumentation Laboratory CO20172—
+2K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO20162—
+2K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO201601
+2K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+3K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+3K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—