
Beckman Coulter, Inc.
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ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS is an FDA 510(k)-cleared medical device (K112603) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 3, 2011. Regulation: 8.