FDA 510(k) Applications Submitted by SUSAN BROCCHI

FDA 510(k) Number Submission Date Device Name Applicant
K090628 03/09/2009 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 BAYER HEALTHCARE, LLC
K121576 05/30/2012 IMMULITE 2000 ANTI-CCP IGG ASSAY Siemens Healthcare Diagnostics Inc.
K152061 07/24/2015 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K133122 09/30/2013 IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) Siemens Healthcare Diagnostics Inc.
K093930 12/22/2009 DIDGET WORLD REPORTS BAYER HEALTHCARE LLC


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