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Etest Cefdinir

by Ab Biodisk Sweden 510(k)

510(k) K980877

Product code JWY

Overview

ETEST CEFDINIR is a Manual Antimicrobial Susceptibility Test System used in microbiology to determine the susceptibility of microorganisms to the antibiotic cefdinir. It is a device designed for laboratory use in testing bacterial resistance patterns.

The device is supplied as a test system for in vitro diagnostic use and is classified under FDA regulation number 866.1640. It received FDA 510(k) clearance (K980877) as substantially equivalent to a predicate device, with product code JWY and is intended for use in clinical microbiology laboratories.

Summary written by AI from registry data, 21 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 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980877 Date6 Jul 1998ClearedStatusActive

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 America
  • Active
  • 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

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Questions

  • What is the ETEST CEFDINIR used for?

    The ETEST CEFDINIR is used to determine the susceptibility of microorganisms to the antibiotic cefdinir by measuring bacterial resistance patterns in vitro, supporting clinical microbiology laboratories in guiding antimicrobial therapy decisions.

  • How is the ETEST CEFDINIR supplied and intended for use?

    The ETEST CEFDINIR is supplied as a test system for in vitro diagnostic use and is intended for manual use in clinical microbiology laboratories to perform antimicrobial susceptibility testing of bacteria against cefdinir.

  • What regulatory pathway was used for the ETEST CEFDINIR?

    The ETEST CEFDINIR received FDA 510(k) clearance (K980877) as substantially equivalent to a predicate device, with product code JWY and classified under FDA regulation number 866.1640 for Manual Antimicrobial Susceptibility Test Systems.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K980877 24 fields · synced 6 Oct 2026