
Immuchem Corp.
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IMMUCHEM COVALENT COAT SOLID PHASE ASSAY is an FDA 510(k)-cleared medical device (K791664) manufactured by Immuchem Corp.. 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 September 26, 1979. Regulation: 8.