
Helena Laboratories
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REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 is an FDA 510(k)-cleared medical device (K940679) 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 September 8, 1994. Regulation: 8.