ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05

ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 is an FDA 510(k)-cleared medical device (K984073) 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 November 24, 1998. Regulation: 8.