BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT is an FDA 510(k)-cleared medical device (K983113) manufactured by Syntron Bioresearch, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 17, 1998. Regulation: 8.