
Bayer Corp.
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ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM is an FDA 510(k)-cleared medical device (K991817) manufactured by Bayer Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1999. Regulation: 8.