Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Armkel, LLC
Free shipping on orders over $99 · 30-day returns
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST is an FDA 510(k)-cleared medical device (K040866) 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 18, 2004. Regulation: 8.