BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

System, Blood Culturing

BioMerieux, Inc.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Virtuo Microbial Detection System, Bact/alert Virtuo, Virtuo.

Pre-market Notification Details

Device IDK161816
510k NumberK161816
Device Name:BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
ClassificationSystem, Blood Culturing
Applicant bioMerieux, Inc. 595 Anglum Rd. Hazelwood,  MO  63042
ContactJolyn Tenllado
CorrespondentJolyn Tenllado
bioMerieux, Inc. 595 Anglum Rd. Hazelwood,  MO  63042
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-01
Decision Date2017-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026614546 K161816 000
03573026369774 K161816 000
03573026369767 K161816 000
03573026629649 K161816 000

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