Cleared Traditional

K830731 - NETILMICIN 30 MCG ANTIMICROBIAL DISK

K830731 is the FDA 510(k) clearance for NETILMICIN 30 MCG ANTIMICROBIAL DISK by General Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K830731 · General Diagnostics · Microbiology device
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Apr 1983
Decision
31d
Days
Class 2
Risk

K830731 is an FDA 510(k) clearance for the NETILMICIN 30 MCG ANTIMICROBIAL DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Diagnostics devices

Submission Details

510(k) Number K830731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date April 08, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 292
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K830731.
CEFAXOLIN 30 MCG SENSI-DISC
K831153 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1983
CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
K831179 · General Diagnostics · May 1983
NETILMICIN 30MCG. SENSITIVITY DISCS
K830956 · Difco Laboratories, Inc. · Apr 1983
NETILMICIN 30 MCG SENSI DISC
K830732 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
AZLOCILLIN 75MCG SENSI-DISC
K823800 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
K822809 · General Diagnostics · Nov 1982