QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012

QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 is an FDA 510(k)-cleared medical device (K980532) 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 March 10, 1998. Regulation: 8.