QUANTAPHASE B-12-COBALMIN-FOLATE-

QUANTAPHASE B-12-COBALMIN-FOLATE- is an FDA 510(k)-cleared medical device (K833247) manufactured by Bio-Rad. 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 18, 1983. Regulation: 8.