Mueller-Hinton Agar Plate
by Otisville Biotech, Inc. 510(k)
Active
510(k) K834421
Overview
The Mueller-Hinton Agar Plate is a culture medium used for antimicrobial susceptibility testing, specifically for disk diffusion susceptibility testing using the Kirby-Bauer method. This device is designed to support the growth of microorganisms and facilitate the determination of their susceptibility to various antimicrobial agents. The plate has a 28ml fill and measures 15x100mm.
The Mueller-Hinton Agar Plate is supplied in packages of 10 and is intended for laboratory use in microbiology settings. The device is non-sterile and is not specified as single-use or reusable. It is MRI safe and should be stored according to manufacturer instructions. The device has FDA 510K clearance with product code JTZ and is classified under regulation number 866.1700.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834421 | Date3 Feb 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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
Other devices from Otisville Biotech, Inc.
Questions
What is the Mueller-Hinton Agar Plate used for?
The Mueller-Hinton Agar Plate is a culture medium specifically designed for antimicrobial susceptibility testing, particularly for disk diffusion susceptibility testing using the Kirby-Bauer method. It supports the growth of microorganisms and helps determine their susceptibility to various antimicrobial agents.
How is the Mueller-Hinton Agar Plate supplied and what are its specifications?
The Mueller-Hinton Agar Plate is supplied in packages of 10 plates. Each plate has a 28ml fill and measures 15x100mm. It is non-sterile and is intended for laboratory use in microbiology settings. The device is MRI safe and should be stored according to manufacturer instructions.
Is the Mueller-Hinton Agar Plate single-use or reusable?
The Mueller-Hinton Agar Plate is not specified as single-use or reusable in the device data. It is a laboratory culture medium that is typically used for testing purposes, but the specific reuse instructions would depend on laboratory protocols and manufacturer guidelines.
What is the regulatory status of the Mueller-Hinton Agar Plate?
The Mueller-Hinton Agar Plate has FDA 510K clearance with product code JTZ and is classified under regulation number 866.1700. It is classified as a Class II device and is substantially equivalent to other devices of its type.