Netilmicin 30MCG Sensitivity Discs
by Difco Laboratories, Inc. 510(k)
Active
510(k) K830956
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830956 | Date27 Apr 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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
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.
Questions
AI-generated answers, 27 Sep 2026
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.