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Mueller Hinton Agar W/4% Nacl W/Antibiotics

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850291

by Remel Co.

Identifiers

510(k) Number
K850291 FDA 510(k)
FDA Product Code
JTZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1700 FDA 510(k)
Regulation Number
866.1700 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mueller Hinton Agar with 4% NaCl and Antibiotics is a solid culture medium classified as an antimicrobial susceptibility test medium. It is specifically designed for qualitative antimicrobial susceptibility testing using the disk diffusion method, enabling the assessment of bacterial resistance profiles.

This medium is supplied as a non-sterile powder for laboratory preparation and requires reconstitution with sterile water. It is intended for use in microbiology settings, particularly for screening Staphylococcus aureus for resistance to penicillinase-resistant penicillins (e.g., methicillin, nafcillin, and oxacillin). The device holds an FDA 510(k) clearance (K850291) and falls under Class II regulatory classification (21 CFR 866.1700).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF MUELLER HINTON AGAR - Thermo Fisher Scientific, Mueller Hinton Agar w/4% NaCl, 6μg/mL Oxacillin, K850291 FDA 510(k) - MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS, PDF MUELLER HINTON AGAR w/ 4% NaCl and 6 μg/ml OXACILLIN SPECIMEN ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Remel Co.

Sources (1)

  • FDA 510(k) K850291 24 fields · synced Sep 19, 2026