
Siemens Healthcare Diagnostics
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DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 is an FDA 510(k)-cleared medical device (K093441) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2010. Regulation: 8.