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Netilmicin 30MCG Sensitivity Discs

by Difco Laboratories, Inc. 510(k)

Active United States

510(k) K830956

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830956 Date27 Apr 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Netilmicin 30MCG Sensitivity Discs are susceptibility test discs used in microbiology for antimicrobial testing. They are designed to determine the sensitivity of microorganisms to netilmicin via disc diffusion methods.

These discs are supplied as a traditional 510(k) cleared device (K830956) by Difco Laboratories, Inc., and are intended for use in laboratory settings. They are non-sterile, single-use in vitro diagnostic products stored under standard conditions, with regulatory classification under 21 CFR 866.1620 and product code JTN.

Other devices from Difco Laboratories, Inc.

See all devices from Difco Laboratories, Inc. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Netilmicin 30MCG Sensitivity Discs used for?

    Netilmicin 30MCG Sensitivity Discs are used in microbiology laboratories to determine the sensitivity of microorganisms to netilmicin through disc diffusion methods, which is a standard technique for antimicrobial susceptibility testing.

  • Are Netilmicin 30MCG Sensitivity Discs sterile or non-sterile, and are they single-use or reusable?

    Netilmicin 30MCG Sensitivity Discs are non-sterile and designed for single-use only, as they are in vitro diagnostic products intended for one-time application in laboratory testing to avoid cross-contamination and ensure accurate results.

  • How are Netilmicin 30MCG Sensitivity Discs supplied and stored?

    Netilmicin 30MCG Sensitivity Discs are supplied as traditional 510(k) cleared devices by Difco Laboratories, Inc., and are stored under standard laboratory conditions without special requirements, as they are non-sterile and stable under normal storage environments.