510(k) K032663

QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 by Instrumentation Laboratory CO — Product Code DCK

K032663 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.