ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 is an FDA 510(k)-cleared medical device (K984626) manufactured by Bio-Rad. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 28, 1999. Regulation: 8.