
Hycor Biomedical, Inc.
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HYTEC AUTOMIMMUNE KIT (RF) is an FDA 510(k)-cleared medical device (K954892) manufactured by Hycor Biomedical, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 25, 1995. Regulation: 8.