VIDAS B.R.A.H.M.S. PCT (PCT)

Procalcitonin Assay

BioMerieux, Inc

The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vidas B.r.a.h.m.s. Pct (pct).

Pre-market Notification Details

Device IDK162827
510k NumberK162827
Device Name:VIDAS B.R.A.H.M.S. PCT (PCT)
ClassificationProcalcitonin Assay
Applicant bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
ContactJohn Albright
CorrespondentJohn Albright
bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
Product CodePRI  
Subsequent Product CodeNTM
Subsequent Product CodePMT
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-07
Decision Date2017-02-23
Summary:summary

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