VITAMIN B12 RADIOASSAY KIT CA-1534

VITAMIN B12 RADIOASSAY KIT CA-1534 is an FDA 510(k)-cleared medical device (K832710) manufactured by Clinical Assays, Inc.. 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 3, 1983. Regulation: 8.