Gentamicin Disk (120MCG)

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

510(k) Number

K961818 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rpr Card Test Kit

  Class II

  FDA 510(k) K955136 Active Cleared 29 Jul 1996

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  Class I

  FDA 510(k) K961046 Active Cleared 18 Sep 1996

• Remel Meropenem 10UG Susceptibility Disk

  Class II

  FDA 510(k) K964421 Active Cleared 6 Dec 1996

• Rpr Liquid Controls

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  FDA 510(k) K955143 Active Cleared 30 Jul 1996

• Gc Base W/ 1% Gchi Open recall

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  FDA 510(k) K954986 Active Cleared 16 Feb 1996

• Mueller Hinton Agar with 2% Naci

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  FDA 510(k) K960313 Active Cleared 25 Mar 1996

See all devices from Remel, L.P. →

• What is the Gentamicin Disk 120mcg used for?

  This device is an antimicrobial susceptibility test disc used in microbiology laboratories to determine bacterial sensitivity to gentamicin. It contains 120 mcg of gentamicin per disc and is designed for in vitro diagnostic use to support antibiotic selection based on zone of inhibition measurements.

• How is the Gentamicin Disk 120mcg supplied and is it sterile?

  The disc is supplied as a sterile, single-use product intended for one-time application in susceptibility testing. Sterility ensures no contamination of the test culture, and single-use design prevents cross-contamination between samples, maintaining test accuracy and reliability.

• What regulatory pathway was used for the Gentamicin Disk 120mcg?

  The device received FDA 510(k) clearance through a traditional review pathway, identified by clearance number K961818, granted on July 10, 1996. This pathway demonstrates substantial equivalence to a legally marketed predicate device, allowing its commercial distribution in the United States.