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Siemens Heatlhcare Diagnostics, Inc.
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DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) is an FDA 510(k)-cleared medical device (K102772) manufactured by Siemens Heatlhcare Diagnostics, Inc.. 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 October 6, 2011. Regulation: 8.
