510(k) K893838

MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER by Ciba Corning Diagnostics Corp. — Product Code JQP

K893838 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.