
Hitachi Chemical Diagnostics, Inc.
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CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) is an FDA 510(k)-cleared medical device (K030590) manufactured by Hitachi Chemical Diagnostics, 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 March 20, 2003. Regulation: 8.