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FDA 510(k) Applications Submitted by Kelli Turner
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140404
02/18/2014
ELECSYS CK-MB STAT IMMUNOASSAY
Roche Diagnostics
K141426
05/30/2014
ELECSYS FOLATE III
Roche Diagnostics
K151786
07/01/2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
Roche Diagnostics
K142021
07/25/2014
Elecsys Estradiol III CalSet
Roche Diagnostics
K142127
08/04/2014
ELECSYS ESTRADIOL III CALCHECK 5
Roche Diagnostics
K152227
08/07/2015
Elecsys Cortisol II, Cortisol II CalSet
ROCHE DIAGNOSTICS
K132571
08/15/2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
Roche Diagnostics
K132828
09/09/2013
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
Roche Diagnostics
K162678
09/26/2016
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
ROCHE DIAGNOSTICS
K133284
10/25/2013
ELECSYS CK-MB CALCHECK 5
Roche Diagnostics
K143284
11/17/2014
Elecsys Estradiol III Calcheck
ROCHE DIAGNOSTICS
K143342
11/21/2014
Elecsys T-Uptake Calset
Roche Diagnostics
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