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Alere San Diego, Inc (Formally Biosite Incorporate
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INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP is an FDA 510(k)-cleared medical device (K110212) manufactured by Alere San Diego, Inc (Formally Biosite Incorporate. 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 30, 2012. Regulation: 8.