HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE

HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE is an FDA 510(k)-cleared medical device (K941765) manufactured by Tcpi, Inc.. 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 19, 1994. Regulation: 8.