CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY is an FDA 510(k)-cleared medical device (K032159) manufactured by Access Bio Incorporate. 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 September 4, 2003. Regulation: 8.