Elecsys BRAHMS PCT

Procalcitonin Assay

Roche Diagnostics

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

Pre-market Notification Details

Device IDK192815
510k NumberK192815
Device Name:Elecsys BRAHMS PCT
ClassificationProcalcitonin Assay
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactWes Gerbig
CorrespondentWes Gerbig
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodePRI  
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-09

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