ASSERACHROM FREE PROTEIN S KIT

ASSERACHROM FREE PROTEIN S KIT is an FDA 510(k)-cleared medical device (K954017) manufactured by American Bioproducts Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1995. Regulation: 8.