SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 is an FDA 510(k)-cleared medical device (K020467) manufactured by Helena Laboratories. 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 March 28, 2002. Regulation: 8.