FDA 510(k) Applications Submitted by JULIE WARREN

FDA 510(k) Number Submission Date Device Name Applicant
K170065 01/09/2017 ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc.
K200256 02/03/2020 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc.
K221605 06/02/2022 Emit« II Plus Buprenorphine Assay Siemens Healthcare Diagnostics, Inc.
K151529 06/08/2015 Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC.


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