OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP is an FDA 510(k)-cleared medical device (K930185) manufactured by Princeton Biomedix. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 3, 1993. Regulation: 8.