SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST

SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST is an FDA 510(k)-cleared medical device (K974851) manufactured by San Diego Biotech. 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 January 21, 1998. Regulation: 8.