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Siemens Healthcare Diagnostics
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ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) is an FDA 510(k)-cleared medical device (K083386) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2009. Regulation: 8.