
Sangstat Medical Corp.
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THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES is an FDA 510(k)-cleared medical device (K973203) manufactured by Sangstat Medical Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 1998. Regulation: 8.