
Armkel, LLC
Free shipping on orders over $99 · 30-day returns
BRAND NAME *1-STEP PREGNANCY is an FDA 510(k)-cleared medical device (K973352) manufactured by Armkel, LLC. 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 26, 1997. Regulation: 8.