ELECSYS T4 CALCHECK 5

Single (specified) Analyte Controls (assayed And Unassayed)

ROCHE DIAGNOSTICS CORPORATION

The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Elecsys T4 Calcheck 5.

Pre-market Notification Details

Device IDK112528
510k NumberK112528
Device Name:ELECSYS T4 CALCHECK 5
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ROCHE DIAGNOSTICS CORPORATION 9115 HAGUE ROAD PO BOX 50416 Indianapolis,  IN  46250 -0416
ContactMichael Leuther
CorrespondentMichael Leuther
ROCHE DIAGNOSTICS CORPORATION 9115 HAGUE ROAD PO BOX 50416 Indianapolis,  IN  46250 -0416
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-31
Decision Date2011-10-18
Summary:summary

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