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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K142811
Device Name IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
Original Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict avenue
tarrytown,  NY  10591
Original Contact asha gartland
Regulation Number862.1660
Classification Product Code
Date Received09/29/2014
Decision Date 10/29/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No