Elecsys Estradiol III Calcheck

Single (specified) Analyte Controls (assayed And Unassayed)

ROCHE DIAGNOSTICS

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Estradiol Iii Calcheck.

Pre-market Notification Details

Device IDK143284
510k NumberK143284
Device Name:Elecsys Estradiol III Calcheck
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis,  IN  46250
ContactKelli Turner
CorrespondentKelli Turner
ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis,  IN  46250
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-17
Decision Date2014-12-16
Summary:summary

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