PRECO PREGNANCY RAPID CARD TEST, HEM #2028

PRECO PREGNANCY RAPID CARD TEST, HEM #2028 is an FDA 510(k)-cleared medical device (K850604) manufactured by Preco, 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 April 7, 1985. Regulation: 8.