RESULT PLUS/HCG PREGNANCY TEST

RESULT PLUS/HCG PREGNANCY TEST is an FDA 510(k)-cleared medical device (K872730) manufactured by Ortho Diagnostic Systems, 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 October 19, 1987. Regulation: 8.