BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL

BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL is an FDA 510(k)-cleared medical device (K030801) manufactured by Bayer Healthcare, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 8, 2003. Regulation: 8.