
Gelman Instrument Co.
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RADIAL IMMUNODIFFUSION KIT-COMP. 3 is an FDA 510(k)-cleared medical device (K772073) manufactured by Gelman Instrument Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1978. Regulation: 8.