BACTON(TM), AUTO-APO A-1 REAGENT

BACTON(TM), AUTO-APO A-1 REAGENT is an FDA 510(k)-cleared medical device (K921795) manufactured by Bacton Assay Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 22, 1992. Regulation: 8.