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Etest Submission for Azithromycin

by Ab Biodisk Sweden(FDA 510(k) applicant) 510(k)

510(k) K961519 Product code JWY

Overview

The ETEST SUBMISSION FOR AZITHROMYCIN is a manual antimicrobial susceptibility test system used to determine the effectiveness of azithromycin against various microorganisms. This device employs a method that allows for the quantitative assessment of antimicrobial susceptibility through the use of predefined concentration gradients.

The device is supplied as a single-use product and is intended for laboratory use in microbiology settings. It is classified as Class II under special controls with product code JWY and regulation number 866.1640. The device received FDA clearance on July 5, 1996, with the decision code SESE indicating it was found to be substantially equivalent to predicate devices.

Summary written by AI from registry data, 24 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961519 Date5 Jul 1996ClearedStatusActive

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: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Ab Biodisk

See all devices from Ab Biodisk →

Questions

  • What is the ETEST SUBMISSION FOR AZITHROMYCIN used for?

    The ETEST SUBMISSION FOR AZITHROMYCIN is a manual antimicrobial susceptibility test system used to determine the effectiveness of azithromycin against various microorganisms through quantitative assessment using predefined concentration gradients.

  • How is the ETEST SUBMISSION FOR AZITHROMYCIN supplied?

    The device is supplied as a single-use product intended for laboratory use in microbiology settings. Each unit is designed for one-time use to ensure accurate test results and prevent cross-contamination.

  • What is the regulatory classification of the ETEST SUBMISSION FOR AZITHROMYCIN?

    The device is classified as Class II under special controls with product code JWY and regulation number 866.1640. It received FDA clearance on July 5, 1996, with decision code SESE indicating substantial equivalence to predicate devices.

  • What are the specifications of the ETEST SUBMISSION FOR AZITHROMYCIN?

    The device is a manual antimicrobial susceptibility test system with a statement summary indicating it is substantially equivalent. It was reviewed by the Microbiology advisory committee and received traditional clearance with K-number K961519.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K961519 24 fields · synced 6 Oct 2026