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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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