
Electrophoresis Corp. of America
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LDH ISOENZYME REAGENT is an FDA 510(k)-cleared medical device (K791657) manufactured by Electrophoresis Corp. of America. 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 16, 1979. Regulation: 8.