
Dade, Baxter Travenol Diagnostics, Inc.
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WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 is an FDA 510(k)-cleared medical device (K800296) manufactured by Dade, Baxter Travenol Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 1980. Regulation: 8.