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Mueller Hinton Broth

by Hardy Media 510(k)

Active United States

510(k) K880105

Overview

Mueller Hinton Broth is a culture media used for the cultivation of a wide variety of microorganisms and for antimicrobial susceptibility testing of aerobic microorganisms by broth dilution methods. It is a type of antimicrobial susceptibility test medium, classified as a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth. The device is used in microbiology applications.

Mueller Hinton Broth is supplied in various sizes, including 500gm. It is a dehydrated culture media that requires preparation before use. The device has received FDA 510K authorization, with a decision description of Substantially Equivalent. The product code for this device is JTZ, and it is classified under regulation number 866.1700.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880105 Date30 Mar 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Muller Hinton Broth
510(k) Number
FDA Product Code
JTZ
Device Class
Class II
Regulation
21 CFR Part 866.1700
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is Mueller Hinton Broth used for?

    Mueller Hinton Broth is used for the cultivation of microorganisms and antimicrobial susceptibility testing of aerobic microorganisms by broth dilution methods.

  • How is Mueller Hinton Broth supplied?

    Mueller Hinton Broth is supplied in various sizes, including 500gm, and is a dehydrated culture media that requires preparation before use.

  • Is Mueller Hinton Broth sterile?

    The device data does not explicitly state that Mueller Hinton Broth is sterile, but it is a culture media used in microbiology applications.

  • What is the regulatory classification of Mueller Hinton Broth?

    Mueller Hinton Broth is classified under regulation number 866.1700, with a product code of JTZ, and has received FDA 510K authorization.