FDA 510(k) Applications Submitted by Garo Mimaryan

FDA 510(k) Number Submission Date Device Name Applicant
K140541 03/04/2014 IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C Siemens Healthcare Diagnostics Inc.
K131536 05/29/2013 IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K131662 06/07/2013 IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K132391 08/01/2013 IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL SIEMENS HELATHCARE DIAGNOSTICS INC.
K122534 08/20/2012 IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc.
K112523 08/31/2011 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics Inc.
K132739 09/03/2013 IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K133124 09/30/2013 IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA Siemens Healthcare Diagnostics Inc.
K103683 12/17/2010 IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) SIEMENS HEALTHCARE DIAGNOSTICS


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