Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecys Brahms Pct, Elecys Brahms Pct Calcheck 5.

Pre-market Notification Details

Device IDK160729
510k NumberK160729
Device Name:Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
ClassificationDevice To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactAdam Clark
CorrespondentAdam Clark
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodePMT  
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-16
Decision Date2016-06-13
Summary:summary

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