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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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