FDA 510(k) Applications Submitted by Edie Eads

FDA 510(k) Number Submission Date Device Name Applicant
K190773 03/26/2019 Elecsys TSH Roche Diagnostics
K131244 05/01/2013 ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET Roche Diagnostics
K221890 06/29/2022 Elecsys Tg II Roche Diagnostics
K122242 07/27/2012 ELECSYS CA 15-3 II CALCHECK 5 Roche Diagnostics
K153301 11/13/2015 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II ROCHE DIAGNOSTICS
DEN150057 12/09/2015 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 ROCHE DIAGNOSTICS
K203757 12/23/2020 Elecsys AMH Roche Diagnostics


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