Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
FDA 510(k) cleared devices by Instrumentation Laboratory CO Chemistry ✕
119 devices
Cleared
Jan 27, 2023
GEM Premier ChemSTAT
Chemistry
119d
Cleared
Aug 20, 2021
GEM Premier 5000
Chemistry
235d
Cleared
Feb 16, 2019
GEM Premier ChemSTAT
Chemistry
58d
Cleared
Feb 16, 2019
GEM Premier ChemSTAT
Chemistry
58d
Cleared
Feb 16, 2019
GEM Premier ChemSTAT
Chemistry
58d
Cleared
Dec 29, 2017
GEM Premier 5000
Chemistry
59d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized...
Chemistry
320d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
Chemistry
306d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
Chemistry
306d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin,...
Chemistry
306d
Cleared
Sep 14, 2016
GEM Premier 3000
Chemistry
75d
Cleared
Jan 13, 2014
GEM PREMIER 4000
Chemistry
68d
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