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Siemens Healthcare Diagnostics, Inc.
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IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL is an FDA 510(k)-cleared medical device (K122534) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 13, 2013. Regulation: 8.