QUICK CARD HCG ONE STEP PREGNANCY TEST

QUICK CARD HCG ONE STEP PREGNANCY TEST is an FDA 510(k)-cleared medical device (K973570) manufactured by Phamatech. 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 October 30, 1997. Regulation: 8.