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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 the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) 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. The listed applicant is bioMerieux, Inc.. The 510(k) number is K190405.

When did BACT/ALERT MP Reagent System receive FDA 510(k) clearance?

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

Who is the listed applicant for BACT/ALERT MP Reagent System?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: MDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260213BD BACTEC FXI Culture SystemBD Diagnostic SystemsK222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and CompanyK222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and CompanyK183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and CompanyK161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc.

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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