510(k) Report

Devices descending from K093623

12 later devices reach Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO20162—
+1K112995Gem Premier 4000Instrumentation Laboratory CO201211—
+2K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+2K133407Gem Premier 4000Instrumentation Laboratory CO201410—
+3K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+3K183549GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+3K183546GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+3K173403GEM Premier 5000Instrumentation Laboratory CO20172—
+3K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO20162—
+3K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO201601
+3K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+4K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—