510(k) K093623

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO by Instrumentation Laboratory CO — Product Code CIG

K093623 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO". The FDA issued a decision of Substantially Equivalent on June 18, 2010. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.