IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL

IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL is an FDA 510(k)-cleared medical device (K131536) 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 August 11, 2013. Regulation: 8.