
Instrumentation Laboratory CO
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GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) is an FDA 510(k)-cleared medical device (K160402) manufactured by Instrumentation Laboratory CO. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2016. Regulation: 8.