510(k) K110780

ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II by Elitechgroup — Product Code CIG

K110780 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II". The FDA issued a decision of Substantially Equivalent on October 7, 2011. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Elitechgroup has at least 10 other 510(k) clearances on record.