
Bayer Healthcare, LLC
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ADVIA IMS VALPROIC ACID METHOD is an FDA 510(k)-cleared medical device (K042807) manufactured by Bayer Healthcare, LLC. 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 February 7, 2005. Regulation: 8.