VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY

VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY is an FDA 510(k)-cleared medical device (K926342) manufactured by Syva Co.. 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 February 16, 1993. Regulation: 8.