ELECSYS ESTRADIOL III CALCHECK 5

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 5.

Pre-market Notification Details

Device IDK142127
510k NumberK142127
Device Name:ELECSYS ESTRADIOL III CALCHECK 5
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Roche Diagnostics 9115 HAGUE ROAD Indianapolis,  IN  46250 -0416
ContactKelli Turner
CorrespondentKelli Turner
Roche Diagnostics 9115 HAGUE ROAD Indianapolis,  IN  46250 -0416
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2014-09-05
Summary:summary

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