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Helena Laboratories
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SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 is an FDA 510(k)-cleared medical device (K020625) 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 May 5, 2002. Regulation: 8.