
Helena Laboratories
Free shipping on orders over $99 · 30-day returns
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 is an FDA 510(k)-cleared medical device (K893211) 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 June 18, 1989. Regulation: 8.