QUICKCARD HCG COMBO TEST, MODEL #9014

QUICKCARD HCG COMBO TEST, MODEL #9014 is an FDA 510(k)-cleared medical device (K991095) 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 April 27, 1999. Regulation: 8.