ELECSYS PRECICONTROL TS

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 Precicontrol Ts.

Pre-market Notification Details

Device IDK140534
510k NumberK140534
Device Name:ELECSYS PRECICONTROL TS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactJane Phillips
CorrespondentJane Phillips
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-04
Decision Date2014-03-27
Summary:summary

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