
Paragondx, LLC
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RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA is an FDA 510(k)-cleared medical device (K071867) manufactured by Paragondx, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2008. Regulation: 8.