Cleared Traditional

BacT/ALERT FA Plus; BacT/ALERT PF Plus

K183166 · bioMerieux, Inc. · Microbiology
Feb 2019
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K183166 is an FDA 510(k) clearance for the BacT/ALERT FA Plus; BacT/ALERT PF Plus, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 11, 2019, 88 days after receiving the submission on November 15, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K183166 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2018
Decision Date February 11, 2019
Days to Decision 88 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

Similar Devices — MDB System, Blood Culturing

All 66
BD BACTEC? Myco/F Lytic Culture Vials
K222559 · Becton, Dickinson and Company · Mar 2023
BD BACTEC? Plus Aerobic/F Culture Vials
K222591 · Becton, Dickinson and Company · Mar 2023
BACT/ALERT MP Reagent System
K190405 · bioMerieux, Inc. · May 2019
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
K173873 · Becton, Dickinson and Company · Mar 2018
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · bioMerieux, Inc. · Mar 2017
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
K161810 · Becton Dickinson · Feb 2017