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Defazolin 30MCG Sensitivity Discs

by Difco Laboratories, Inc.

510(k) K832910

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832910 Date14 Nov 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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, 20 Sep 2026

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

The Defazolin 30mcg Sensitivity Discs are antimicrobial susceptibility test discs used to determine bacterial sensitivity to cephalosporins. Classified as susceptibility test discs under the nomenclature authority, these discs facilitate in vitro testing to evaluate microbial resistance or susceptibility, aiding in appropriate antibiotic selection for clinical treatment.

These discs are supplied in sterile, single-use form for microbiological laboratory use. They are intended for use in disc diffusion testing, a standard method in microbiology to assess bacterial growth inhibition. The product is regulated under FDA 510(k) clearance (K832910) and falls under Class II medical devices, adhering to regulatory standards for antimicrobial susceptibility testing. Storage and handling follow standard aseptic practices to maintain sterility and accuracy of results.

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Questions

AI-generated answers, 20 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 is the primary use of the Defazolin 30mcg Sensitivity Discs in a clinical setting?

    The Defazolin 30mcg Sensitivity Discs are designed for in vitro antimicrobial susceptibility testing, specifically to evaluate how bacteria respond to cephalosporin antibiotics. Clinicians use them in disc diffusion testing to determine whether bacterial isolates are resistant or susceptible to cephalosporins, helping guide appropriate antibiotic treatment decisions.

  • Are these discs meant for single-use or can they be reused?

    These discs are explicitly supplied as sterile and intended for single-use only. Reusing them could compromise sterility and the accuracy of test results, which is critical for reliable antimicrobial susceptibility assessments in microbiology labs.

  • How should the Defazolin 30mcg Sensitivity Discs be stored to maintain their integrity?

    The discs must be stored following standard aseptic practices to preserve sterility and ensure accurate testing. While the data doesn’t specify exact storage conditions, they should be kept in a clean, dry environment away from direct light and contamination until use, as with most sterile microbiological supplies.

  • What regulatory pathway was followed for the approval of these discs?

    The Defazolin 30mcg Sensitivity Discs were cleared through the FDA’s 510(k) process, specifically under a *Traditional* clearance route. The submission was reviewed by the Microbiology (MI) advisory committee and classified as substantially equivalent to a predicate device, with the clearance number K832910.