IAFP Mueller Hinton Agar
by I.A.F. Production, Inc. 510(k)
Active
510(k) K872686
Overview
IAFP Mueller Hinton Agar is a culture media device used for antimicrobial susceptibility testing in microbiology laboratories. It is a Class 2 device with product code LKA, designed to support the growth of microorganisms for determining their sensitivity to antimicrobial agents.
The device is manufactured by I.A.F. Production, Inc. and was cleared through the Traditional 510(k) pathway on August 11, 1987. It is supplied as a ready-to-use agar and is intended for laboratory use only. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872686 | Date11 Aug 1987 | 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- Withdrawn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
- LKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1700
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from I.A.F. Production, Inc.
Questions
What is IAFP Mueller Hinton Agar used for?
IAFP Mueller Hinton Agar is a culture media device used for antimicrobial susceptibility testing in microbiology laboratories. It supports the growth of microorganisms to determine their sensitivity to antimicrobial agents.
How is IAFP Mueller Hinton Agar supplied?
The device is supplied as a ready-to-use agar, intended for laboratory use only. No information is provided regarding whether it is single-use or reusable.
What is the regulatory status of IAFP Mueller Hinton Agar?
IAFP Mueller Hinton Agar is a Class 2 device with product code LKA. It was cleared through the Traditional 510(k) pathway on August 11, 1987, and is substantially equivalent to other devices in this category.
Are there any specific storage conditions for IAFP Mueller Hinton Agar?
No information regarding storage conditions for IAFP Mueller Hinton Agar is provided in the device data.