510(k) Report

Devices descending from K010520

18 later devices reach Gem Premier 3000- Addition of Glucose and Lactate as New Parameters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022158Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration…Instrumentation Laboratory CO200217—
+2K052121Gem Premier 3000Instrumentation Laboratory CO2005162
+3K161818GEM Premier 3000Instrumentation Laboratory CO201603
+3K061974Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Instrumentation Laboratory CO2006144
+4K112995Gem Premier 4000Instrumentation Laboratory CO201211—
+4K093280Opti Cca-TS, B-Lac Cassette Model BP7561Opti Medical Systems, Inc.201101
+4K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO2010125
+5K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO20162—
+5K133407Gem Premier 4000Instrumentation Laboratory CO201410—
+6K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+6K183549GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+6K183546GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+6K173403GEM Premier 5000Instrumentation Laboratory CO20172—
+6K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO20162—
+6K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO201601
+6K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+7K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+7K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—