
Hycor Biomedical
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Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria is an FDA 510(k)-cleared medical device (K220162) manufactured by Hycor Biomedical. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 17, 2022. Regulation: 8.