ACCURATE BETA 30 PREGNANCY TEST KIT

ACCURATE BETA 30 PREGNANCY TEST KIT is an FDA 510(k)-cleared medical device (K841602) manufactured by Organon, 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 21, 1984. Regulation: 8.