FDA 510(k) Applications Submitted by SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K091984 07/02/2009 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K071017 04/10/2007 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K100910 04/01/2010 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K071455 05/25/2007 ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K072794 10/01/2007 IMMULITE 2500 OM-MA, MODEL L5KOP SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K071466 05/29/2007 DCA VANTAGE, MODEL 5075 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K073537 12/17/2007 NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K070727 03/15/2007 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K081895 07/03/2008 ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K072204 08/08/2007 ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K072658 09/20/2007 ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS


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