
Siemens Healthcare Diagnostics, Inc.
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DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE is an FDA 510(k)-cleared medical device (K133728) manufactured by Siemens Healthcare Diagnostics, Inc.. 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 January 23, 2014. Regulation: 8.