BIOSIGN HCG-ONE STEP PREGNANCY TEST

BIOSIGN HCG-ONE STEP PREGNANCY TEST is an FDA 510(k)-cleared medical device (K901011) manufactured by Princeton Biomedix. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1990. Regulation: 8.