
International Enzymes, Inc.
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LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM is an FDA 510(k)-cleared medical device (K953926) manufactured by International Enzymes, 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 September 14, 1995. Regulation: 8.