RIANEN, VITAMIN B12 ASSAY SYSTEM

RIANEN, VITAMIN B12 ASSAY SYSTEM is an FDA 510(k)-cleared medical device (K792175) manufactured by New England Nuclear. 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 November 12, 1979. Regulation: 8.