FDA 510(k) Applications Submitted by Donna Velasquez

FDA 510(k) Number Submission Date Device Name Applicant
K100910 04/01/2010 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K141444 06/02/2014 IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL Siemens Healthcare Diagnostics Inc.
K142878 10/02/2014 IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143373 11/25/2014 IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143636 12/22/2014 IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K093987 12/24/2009 IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 Siemens Healthcare Diagnostics Inc.


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