ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05

ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 is an FDA 510(k)-cleared medical device (K984625) 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 February 1, 1999. Regulation: 8.