QUICKCARD PRO HCG TEST, MODEL 9008

QUICKCARD PRO HCG TEST, MODEL 9008 is an FDA 510(k)-cleared medical device (K980896) 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 1, 1998. Regulation: 8.