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FDA 510(k)

BACT/ALERT MP Reagent System

K-Number: K190405 · 2019-05-15

ApplicantbioMerieux, Inc.
Decision Date2019-05-15
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT MP Reagent System is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2019-05-15 under approval number K190405. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACT/ALERT MP Reagent System?

BACT/ALERT MP Reagent System is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by bioMerieux, Inc.. The 510(k) number is K190405.

When was BACT/ALERT MP Reagent System approved by the FDA?

BACT/ALERT MP Reagent System received FDA 510(k) clearance on 2019-05-15, under approval number K190405.

What company makes BACT/ALERT MP Reagent System?

BACT/ALERT MP Reagent System is manufactured by bioMerieux, Inc..

What is the FDA product code for BACT/ALERT MP Reagent System?

The FDA product code for BACT/ALERT MP Reagent System is MDB.

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Related PubMed Literature

PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025)

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Related Devices (Code: MDB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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