PREGNA-CERT, SLIDE PREGNANCY TEST

PREGNA-CERT, SLIDE PREGNANCY TEST is an FDA 510(k)-cleared medical device (K831180) manufactured by Diagnostic Specialties. 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 May 26, 1983. Regulation: 8.