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IAFP Mueller Hinton Agar

by I.A.F. Production, Inc. 510(k)

Active United States

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.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872686 Date11 Aug 1987ClearedStatusActive

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
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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.

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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.