ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT is an FDA 510(k)-cleared medical device (K955707) 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 May 1, 1996. Regulation: 8.