BIOSIGN HCG I - ONE STEP PREGNANCY TEST

BIOSIGN HCG I - ONE STEP PREGNANCY TEST is an FDA 510(k)-cleared medical device (K981443) manufactured by Princeton BioMeditech Corp.. 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 June 24, 1998. Regulation: 8.