B-SLIDE PREGNATE PREGNANCY TEST KIT

B-SLIDE PREGNATE PREGNANCY TEST KIT is an FDA 510(k)-cleared medical device (K832879) manufactured by Fisher Scientific Co., LLC. 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 27, 1983. Regulation: 8.