BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR is an FDA 510(k)-cleared medical device (K030804) manufactured by Bayer Healthcare, LLC. 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 April 9, 2003. Regulation: 8.