Cleared Traditional

BACT/ALERT MP Reagent System

K190405 · bioMerieux, Inc. · Microbiology
May 2019
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K190405 is an FDA 510(k) clearance for the BACT/ALERT MP Reagent System, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 15, 2019, 85 days after receiving the submission on February 19, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K190405 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2019
Decision Date May 15, 2019
Days to Decision 85 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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