DAXOR MAX100 SYRINGE (MAX100)

DAXOR MAX100 SYRINGE (MAX100) is an FDA 510(k)-cleared medical device (K970419) manufactured by Daxor Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1997. Regulation: 8.