ELECSYS CK-MB 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 Ck-mb Calcheck 5.

Pre-market Notification Details

Device IDK133284
510k NumberK133284
Device Name:ELECSYS CK-MB CALCHECK 5
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 Received2013-10-25
Decision Date2013-11-22
Summary:summary

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