CHIRON DIAGNOSTICS ACS: 180 FOLATE

CHIRON DIAGNOSTICS ACS: 180 FOLATE is an FDA 510(k)-cleared medical device (K991582) manufactured by Chiron Diagnostics Corp.. 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 June 29, 1999. Regulation: 8.