
Bayer Corp.
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CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is an FDA 510(k)-cleared medical device (K964068) manufactured by Bayer Corp.. 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 December 12, 1996. Regulation: 8.