AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST is an FDA 510(k)-cleared medical device (K964574) manufactured by Athena Medical Corp.. 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 January 20, 1997. Regulation: 8.