PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT is an FDA 510(k)-cleared medical device (K896482) manufactured by Pacific Biotech, 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 March 5, 1990. Regulation: 8.