
Helena Laboratories
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REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 is an FDA 510(k)-cleared medical device (K913058) 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 October 29, 1991. Regulation: 8.