ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER

About This 510(k) Submission

K070531 is an FDA 510(k) clearance for the ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Thermo Fisher Scientific (Pittsburgh, US). The FDA issued a Cleared decision on September 4, 2007, 193 days after receiving the submission on February 23, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.