ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

About This 510(k) Submission

K083386 is an FDA 510(k) clearance for the ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL), a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on April 2, 2009, 136 days after receiving the submission on November 17, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.