510(k) K083386

ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) by Siemens Healthcare Diagnostics — Product Code CJY

K083386 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)". The FDA issued a decision of Substantially Equivalent on April 2, 2009. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.