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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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