510(k) K070531

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER by Thermo Fisher Scientific — Product Code CGZ

K070531 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 4, 2007. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.