510(k) K082210

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 by Genzyme Diagnostics P.E.I., Inc. — Product Code CIG

K082210 is an FDA 510(k) premarket notification submitted by Genzyme Diagnostics P.E.I., Inc. for the device "TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30". The FDA issued a decision of Substantially Equivalent on December 16, 2008. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Genzyme Diagnostics P.E.I., Inc. has at least 1 other 510(k) clearance on record.