Cleared Traditional

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

K161816 · bioMerieux, Inc. · Microbiology
Mar 2017
Decision
270d
Days
Class 1
Risk

About This 510(k) Submission

K161816 is an FDA 510(k) clearance for the BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 28, 2017, 270 days after receiving the submission on July 1, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K161816 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2016
Decision Date March 28, 2017
Days to Decision 270 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MDB — System, Blood Culturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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