
Baxter Diagnostics, Inc.
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PARAMAX(R) PHENYTOIN REAGENT is an FDA 510(k)-cleared medical device (K932686) manufactured by Baxter Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 1993. Regulation: 8.