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Remel Azithromlycin 15 Mcg Susceptibility Disk

FDA 510(k)

Class II (US FDA 510(k))

510(k) K933657

by Remel Co.

Identifiers

510(k) Number
K933657 FDA 510(k)
FDA Product Code
JTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1620 FDA 510(k)
Regulation Number
866.1620 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Remel Azithromycin 15 Mcg Susceptibility Disk is an antimicrobial susceptibility test disc used to measure the in vitro susceptibility of clinically important bacterial pathogens to antimicrobial agents. It consists of an antimicrobic-impregnated paper disc designed for use with disc-agar diffusion or disc-broth elution techniques.

This device is classified as a Class II antimicrobial susceptibility test disc under product code JTN. It has received FDA 510(k) clearance under K933657. Users should refer to the manufacturer's instructions for specific storage and handling requirements.

Frequently asked questions

What is the primary use of the Remel Azithromycin 15 Mcg Susceptibility Disk?

This device is an antimicrobial-impregnated paper disc designed to measure the in vitro susceptibility of clinically important bacterial pathogens to azithromycin. It is intended for use with disc-agar diffusion or disc-broth elution laboratory techniques.

How is this susceptibility disk regulated?

The Remel Azithromycin 15 Mcg Susceptibility Disk is classified as a Class II antimicrobial susceptibility test disc under product code JTN. It has received FDA 510(k) clearance under submission number K933657.

What are the storage and handling requirements for these disks?

Users should refer to the specific manufacturer's instructions provided with the product for detailed storage and handling requirements to ensure the integrity and performance of the antimicrobial-impregnated discs.

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: Remel Azithromlycin 15 Mcg Susceptibility Disk, K933657 FDA 510(k) - REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILI..., PDF K933657 - Remel Azithromlycin 15 Mcg Susceptibility Disk, REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK 510(k) K933657 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Remel Co.

Sources (1)

  • FDA 510(k) K933657 24 fields · synced Sep 27, 2026