
R2 Diagnostics, Inc.
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LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA is an FDA 510(k)-cleared medical device (K083878) manufactured by R2 Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 24, 2010. Regulation: 8.