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Mueller Hinton

by Biomerieux, Inc.

510(k) K830060

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830060 Date9 Feb 1983ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Mueller Hinton is a culture media used for antimicrobial susceptibility testing. It is classified as a Class 2 device under FDA regulation 866.1700 with product code JTZ.

The device received FDA 510(k) clearance (K830060) through the traditional pathway on February 9, 1983, and is manufactured by bioMerieux, Inc. in McHenry, Illinois. It is supplied as a microbiological test medium for laboratory use in determining antibiotic susceptibility.

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