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Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
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ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE is an FDA 510(k)-cleared medical device (K120615) manufactured by Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen. 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 May 14, 2013. Regulation: 8.