
Beckman Coulter, Inc.
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ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 is an FDA 510(k)-cleared medical device (K010428) 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 March 12, 2001. Regulation: 8.