AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015

AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 is an FDA 510(k)-cleared medical device (K993141) 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 November 7, 1999. Regulation: 8.