SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 is an FDA 510(k)-cleared medical device (K013466) manufactured by Helena Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 20, 2001. Regulation: 8.