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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