EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST is an FDA 510(k)-cleared medical device (K963231) manufactured by Excel Scientific, 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 December 3, 1996. Regulation: 8.